FDA Regulatory Decisions
510(k) clearances, PMA approvals, and De Novo grants — trailing 120 days, sourced from openFDA
1591 submissions
CompanyDeviceCategoryPathwayDecisionFDA IDDecision DateReview
Endovascular Engineering, Inc.
 Helo™ Return Anesthesiology 510(k) Cleared K253717 Oct 11, 2026 321d
Nexus CMF, LLC
 TruVision Single-Use 1.9mm Arthroscopy System Orthopedic 510(k) Cleared K260156 Oct 9, 2026 262d
Shenzhen Jianchao Intelligent Technology Co., Ltd.
 IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202) Surgical 510(k) Cleared K262352 Oct 9, 2026 91d
CathRx, Ltd.
 Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) Cardiovascular 510(k) Cleared K262068 Oct 9, 2026 109d
Fertilis Pty, Ltd.
 Fertilis microICSI Device Women's Health 510(k) Cleared K262090 Oct 9, 2026 109d
Ischemaview, Inc.
 Rapid ICH (v4.0) Imaging 510(k) Cleared K262301 Oct 9, 2026 94d
Shenzhen Jianchao Intelligent Technology Co., Ltd.
 Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620 … Physical Medicine 510(k) Cleared K262834 Oct 9, 2026 59d
Vivachek Biotech (Hangzhou) Co., Ltd.
 VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System … Diagnostics 510(k) Cleared K260687 Oct 9, 2026 220d
Neurotronics, LLC
 Sleep Analysis Module Neurology 510(k) Cleared K261521 Oct 9, 2026 155d
Stryker Neurovascular
 Excelsior Reach Microcatheter Cardiovascular 510(k) Cleared K261649 Oct 9, 2026 143d
Wishbone SA
 Wishbone HAE Dental 510(k) Cleared K260096 Oct 9, 2026 269d
CarboFix Orhtopedics , Ltd.
 CarboClear® Cervical Navigated Instruments Neurology 510(k) Cleared K263154 Oct 9, 2026 30d
Materialise NV
 CMF Titanium Splints Dental 510(k) Cleared K260913 Oct 9, 2026 204d
Medical Components, Inc.
 Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler General Hospital 510(k) Cleared K260080 Oct 9, 2026 270d
Fujifilm Corporation
 ECHELON Synergy Imaging 510(k) Cleared K262902 Oct 9, 2026 52d
Allwin Medical Devices, Inc.
 The D-Tip Denudation Pipette Women's Health 510(k) Cleared K261234 Oct 9, 2026 177d
Med-El Corp.
 MED-EL Cochlear Implant System Other PMA Supplement Approved P000025/S136 Oct 9, 2026 491d
Medtronic Neuromodulation
 InterStim™ Therapy System, Verify™ Evaluation System Other PMA Supplement Approved (30-day notice) P970004/S459 Oct 9, 2026 29d
Medtronic Neuromodulation
 InterStim™ Therapy System, Verify™ Evaluation System Other PMA Supplement Approved (30-day notice) P080025/S353 Oct 9, 2026 29d
Medtronic, Inc.
 Affera Sphere-9 Mapping and Ablation Catheter Cardiovascular PMA Supplement Approved (30-day notice) P240013/S032 Oct 9, 2026 28d
Organox Limited
 OrganOx metra® System Other PMA Supplement Approved P200035/S038 Oct 9, 2026 168d
Biotronik, Inc.
 Acticor Sky HF-T 481986; Rivacor Sky HF-T 481991; Rivacor Rise HF-T 482017; Rivacor Aura HF-T 482013 … Cardiovascular PMA Supplement Approved P050023/S213 Oct 9, 2026 88d
Biotronik, Inc.
 Edora 8 HF-T QP 407137; Edora 8 HF-T 407138; Evity 8 HF-T QP 407139; Evity 8 HF-T 407140 … Cardiovascular PMA Supplement Approved P070008/S181 Oct 9, 2026 88d
Depuy, Inc.
 ATTUNE Revision Knee System Orthopedic PMA Supplement Approved (30-day notice) P830055/S379 Oct 9, 2026 10d
Biotronik, Inc.
 Edora 8 DR-T 407145; Evity 8 DR-T 407146; Enitra 8 DR-T 407147; Enticos 8 DR-T 407148; Evity 6 DR-T 407149 … Cardiovascular PMA Supplement Approved P950037/S296 Oct 9, 2026 88d
Abbott Medical
 Motorized Outer Tubing Cutter for UltiPace Leads Cardiovascular PMA Supplement Approved (30-day notice) P960013/S135 Oct 9, 2026 29d
Biotronik, Inc.
 Acticor Sky VR-T 481989; Rivacor Sky VR-T 481984; Rivacor Rise VR-T 482020; Rivacor Aura VR-T 482015 … Cardiovascular PMA Supplement Approved P980023/S149 Oct 9, 2026 88d
Biotronik, Inc.
 Acticor Sky DR-T 481987; Rivacor Sky DR-T 481982; Rivacor Rise DR-T 482018; Rivacor Aura DR-T 482014 Cardiovascular PMA Supplement Approved P000009/S132 Oct 9, 2026 88d
Dent4You AG
 One Coat Bond; One Coat Bond SL Dental 510(k) Cleared K263680 Oct 8, 2026 1d
Stryker Instruments
 Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000) … Other 510(k) Cleared K262244 Oct 8, 2026 99d
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
 Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp) … Imaging 510(k) Cleared K261617 Oct 8, 2026 146d
Samsung Medison Co., Ltd.
 V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System … Imaging 510(k) Cleared K263150 Oct 8, 2026 30d
Wuhan Phomed Technology Co., Ltd.
 CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30) … Surgical 510(k) Cleared K262346 Oct 8, 2026 90d
IVT Medical, Ltd.
 MeCare Alpha (MCA2019) Surgical 510(k) Cleared K260426 Oct 8, 2026 240d
Neuroxt, Inc.
 NEXT-Cue Neurology 510(k) Cleared K261805 Oct 8, 2026 129d
Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
 VENTANA MMR RxDx Panel Diagnostics PMA Supplement Approved P210001/S016 Oct 8, 2026 300d
Vistakon, Division of Johnson & Johnson Vision Car
 VISTAKON (SENOFILCON A) Brand Contact Lenses Ophthalmic PMA Supplement Approved (30-day notice) P040045/S146 Oct 8, 2026 20d
W. L. Gore & Associates, Inc.
 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Cardiovascular PMA Supplement Approved P160021/S051 Oct 8, 2026 244d
Croma-Pharma GmbH
 saypha® ChiQ™ Surgical PMA Supplement Approved P250021/S002 Oct 8, 2026 90d
Abbott Medical
 Volt™ PFA Catheter, Sensor Enabled™ Cardiovascular PMA Supplement Approved (30-day notice) P250022/S009 Oct 8, 2026 24d
Ventana Medical Systems
 VENTANA MMR RxDx Panel Diagnostics PMA Supplement Approved P200019/S014 Oct 8, 2026 300d
Abbott Medical
 Volt™ Pfa Catheter, Sensor Enabled™ Cardiovascular PMA Supplement Approved (30-day notice) P250022/S012 Oct 8, 2026 10d
Depuy, Inc.
 ATTUNE Rotating Platform (RP) Total Knee System, ATTUNE Revision Rotating Platform (RP) Total Knee System … Orthopedic PMA Supplement Approved (30-day notice) P830055/S377 Oct 8, 2026 24d
Zhongshan GL Electronics Co. , Ltd.
 Nasal Aspirator (TLC-N02); Electric NoseFrida Pro (12300400); Electric NoseFrida (12100401) Surgical 510(k) Cleared K262822 Oct 7, 2026 58d
Deep Reasoning Ai, Inc.
 NeuroDR Imaging 510(k) Cleared K262134 Oct 7, 2026 104d
Centers for Disease Control and Prevention
 B. anthracis Real-time PCR Assay Diagnostics 510(k) Cleared K262368 Oct 7, 2026 89d
Centinel Spine, LLC
 prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments Orthopedic 510(k) Cleared K263159 Oct 7, 2026 28d
UAB Ligence
 Ligence Heart Imaging 510(k) Cleared K261733 Oct 7, 2026 134d
Ceiba Healthcare US, Inc.
 eClinics Cardiovascular 510(k) Cleared K260075 Oct 7, 2026 268d
InnoDtech, Inc.
 Dr.AlignNavi Dental 510(k) Cleared K262378 Oct 7, 2026 86d
Beijing Nubway S&T Co., Ltd.
 Diode Laser Hair Removal Machine (QDTM-03) Surgical 510(k) Cleared K261692 Oct 7, 2026 138d
Vista AI, Inc.
 Vista AI Scan Imaging 510(k) Cleared K260092 Oct 7, 2026 268d
Paragon 28, Inc.
 APEX 3D S Diamond Tibia Orthopedic 510(k) Cleared K261120 Oct 7, 2026 187d
JenaValve Technology, Inc.
 Trilogy Transcatheter Heart Valve System Cardiovascular PMA Supplement Approved (30-day notice) P250024/S006 Oct 7, 2026 9d
Croma-Pharma GmbH
 saypha® ChiQ™ Surgical PMA Supplement Approved P250021/S001 Oct 7, 2026 89d
Okami Medical, Inc.
 LOBO Vascular Occlusion System Cardiovascular 510(k) Cleared K262798 Oct 6, 2026 60d
Urolution Medical, Inc.
 OpenFlo Urinary Catheter Other 510(k) Cleared K261141 Oct 6, 2026 182d
Bayer Medical Care, Inc.
 MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12) … Cardiovascular 510(k) Cleared K262043 Oct 6, 2026 111d
Anhui JBH Medical Apparatus Co., Ltd.
 Power Wheelchair (DC12) Physical Medicine 510(k) Cleared K261079 Oct 6, 2026 188d
Alembic, LLC
 APRO 88 Catheter Cardiovascular 510(k) Cleared K261938 Oct 6, 2026 118d
Anhui JBH Medical Apparatus Co., Ltd.
 Power Wheelchair (D60) Physical Medicine 510(k) Cleared K261200 Oct 6, 2026 176d
Tsk Laboratory, Japan
 TSK OptiXion General Hospital 510(k) Cleared K262516 Oct 6, 2026 77d
True Function Laboratory, Inc.
 Forza Dental 510(k) Cleared K260136 Oct 6, 2026 263d
NormaTec Industries, LP
 Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST);Normatec Elite Heat (PRO26-TL) … Physical Medicine 510(k) Cleared K261887 Oct 6, 2026 123d
Medtronic Neuromodulation
 InterStim™ Therapy System, Verify™ Evaluation System Other PMA Supplement Approved P970004/S457 Oct 6, 2026 75d
Medtronic, Inc.
 Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ Neurology PMA Supplement Approved P960009/S542 Oct 6, 2026 75d
Zoll Manufacturing Corporation
 LifeVest® Wearable Defibrillator Cardiovascular PMA Supplement Approved (30-day notice) P010030/S205 Oct 6, 2026 25d
Medtronic Neuromodulation
 Master Vanta™ with Restore™, Itrel™, Synergy™, Intellis™ … Neurology PMA Supplement Approved P840001/S632 Oct 6, 2026 75d
Medtronic Neuromodulation
 lnterStim™ Therapy System, Verify™ Evaluation System Other PMA Supplement Approved P080025/S351 Oct 6, 2026 75d
Medtronic, Inc.
 Sphere-9 Catheter™ and Affera™ Ablation System Cardiovascular PMA Supplement Approved P240013/S028 Oct 6, 2026 90d
Biomet Manufacturing Corp
 Cementless Oxford Partial Knee System Orthopedic PMA Supplement Approved (30-day notice) P010014/S119 Oct 6, 2026 43d
Inkspace Imaging, Inc.
 InkSpace Imaging Small Body Array (SBA12PH15x) Imaging 510(k) Cleared K262813 Oct 5, 2026 59d
Medis Medical Imaging Systems BV
 QGuideCT (1.0) Imaging 510(k) Cleared K260523 Oct 5, 2026 230d
Shijiazhuang Recovery Star Medical Device Co., Ltd.
 UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35) Surgical 510(k) Cleared K262285 Oct 5, 2026 91d
HeartSciences, Inc.
 MyoVista wavECG (DG-200-B15-003) Cardiovascular 510(k) Cleared K260005 Oct 5, 2026 276d
Brainlab SE
 RT Elements (4.6) Imaging 510(k) Cleared K261655 Oct 5, 2026 139d
Glytec, LLC
 Glucommander Anesthesiology 510(k) Cleared K261939 Oct 5, 2026 117d
Sichuan Qianli-Beoka Medical Technology, Inc.
 Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1 … Physical Medicine 510(k) Cleared K262812 Oct 5, 2026 59d
Medtronic, Inc.
 Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P … Cardiovascular PMA Supplement Approved (30-day notice) P010015/S590 Oct 5, 2026 26d
Depuy, Inc.
 LCS® Total Knee System Orthopedic PMA Supplement Approved (30-day notice) P830055/S380 Oct 5, 2026 5d
Zoll Manufacturing Corporation
 LifeVest® Wearable Defibrillator Cardiovascular PMA Supplement Approved (30-day notice) P010030/S204 Oct 5, 2026 25d
Biotronik, Inc.
 Edora 8 HF-T QP Edora 8 HF-T Evity 8 HF-T QP Evity 8 HF-T Enitra 8 HF-T QP Enitra 8 HF-T Enticos 8 HF-T QP … Cardiovascular PMA Supplement Approved (30-day notice) P070008/S182 Oct 5, 2026 19d
Guardant Health, Inc.
 Shield Other PMA Supplement Approved (30-day notice) P230009/S021 Oct 5, 2026 25d
Medtronic Cardiac Rhythm Disease Management
 Cobalt MRI ICD (DDPB3Dl, DDPB3D4, DVPB3Dl, DVPB3D4); Cobalt XT MRI ICD (DDPA2Dl, DDPA2D4, DVPA2Dl, DVPA2D4) … Cardiovascular PMA Supplement Approved (30-day notice) P980016/S966 Oct 5, 2026 24d
Medtronic, Inc.
 Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG … Cardiovascular PMA Supplement Approved (30-day notice) P980035/S847 Oct 5, 2026 26d
Medtronic Cardiac Rhythm Disease Management
 Cobalt MRI CRT-D (DTPB2Dl, DTPB2D4, DTPB2Ql, DTPB2QQ) … Cardiovascular PMA Supplement Approved (30-day notice) P010031/S933 Oct 5, 2026 24d
Guidant Corp.
 VALITUDE™ (Model U125); VALITUDE X4 (Model U128); VISIONIST™ (Models U225, U226); VISIONIST X4 (Model U228) Cardiovascular PMA Supplement Approved (30-day notice) P030005/S257 Oct 3, 2026 18d
Boston Scientific Corp
 ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321) … Cardiovascular PMA Supplement Approved (30-day notice) N970003/S311 Oct 3, 2026 18d
Boston Scientific
 ESSENTIO MRI (Model L131); PROPONENT MRI (Model L231); ACCOLADE MRI (Model L331) … Cardiovascular PMA Supplement Approved (30-day notice) P150012/S191 Oct 3, 2026 18d
Gelesis SRL
 Plenity-V (MC0979 / GS110) Other 510(k) Cleared K261783 Oct 2, 2026 126d
Spinal Simplicity, LLC
 Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate … Orthopedic 510(k) Cleared K261607 Oct 2, 2026 141d
GS Medical Co., Ltd.
 AnyPlus II Spinal Fixation System Orthopedic 510(k) Cleared K261217 Oct 2, 2026 171d
I-Sens, Inc.
 CVS Advanced PLUS Blood Glucose Monitoring System Diagnostics 510(k) Cleared K260689 Oct 2, 2026 213d
Lg Electronics.Inc
 Medical Monitor (32MD08WC) Imaging 510(k) Cleared K262985 Oct 2, 2026 36d
GE Medical Systems Ultrasound and Primary care Diagnostics, LLC
 Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 Imaging 510(k) Cleared K261933 Oct 2, 2026 115d
Encore Medical L.P.
 AltiVate Reverse® Glenosphere with RAVN™ Technology Orthopedic 510(k) Cleared K263086 Oct 2, 2026 30d
ZSFab, Inc.
 ZSAlign Cervical Interbody System Orthopedic 510(k) Cleared K263113 Oct 2, 2026 28d
Argus Cognitive, Inc.
 Neurora Neurology 510(k) Cleared K260064 Oct 2, 2026 266d
Aesculap, Inc.
 Ventricular Catheters, Thomale Catheter Neurology 510(k) Cleared K260044 Oct 2, 2026 268d
Roche Diagnostics
 Elecsys EBV EBNA IgG Diagnostics 510(k) Cleared K260221 Oct 2, 2026 249d
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
 Lung Guidance Imaging 510(k) Cleared K261042 Oct 2, 2026 185d
Cognition Medical Corp.
 OAB Delivery Catheter Cardiovascular 510(k) Cleared K253422 Oct 2, 2026 366d
OsteoCentric Technologies
 OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts Orthopedic 510(k) Cleared K263116 Oct 2, 2026 28d
Shenzhen Lifotronic Technology Co., Ltd.
 H100Plus Hemoglobin Testing System Diagnostics 510(k) Cleared K260468 Oct 2, 2026 232d
Steris
 MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope Reprocessor Other 510(k) Cleared K261791 Oct 2, 2026 126d
VPIX Medical, Inc.
 cCeLL405 Neurology 510(k) Cleared K254030 Oct 2, 2026 290d
Tdm Co., Ltd.
 TDM Large Bone Plate and Screw System Orthopedic 510(k) Cleared K261611 Oct 2, 2026 140d
Roche Diagnostics
 Elecsys EBV VCA IgG Diagnostics 510(k) Cleared K260232 Oct 2, 2026 249d
Barco NV
 Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630) Imaging 510(k) Cleared K262412 Oct 2, 2026 79d
Anrei Medical (Hz) Co., Ltd.
 Hemostatic Clip Other 510(k) Cleared K261741 Oct 2, 2026 128d
Remedi, Inc.
 Remex-T(K)100C Imaging 510(k) Cleared K261943 Oct 2, 2026 114d
Shenzhen Ninenovo Technology Limited
 Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12 … Cardiovascular 510(k) Cleared K260490 Oct 2, 2026 231d
Response Ortho Solutions, LLC
 Response Ortho Smart Fixator - Hexapod System Orthopedic 510(k) Cleared K263083 Oct 2, 2026 30d
Ovesco Endoscopy AG
 stentFIX System Set (100.50n) Other 510(k) Cleared K260487 Oct 2, 2026 231d
Cepheid®
 Xpert Xpress CoV-2/Flu plus Diagnostics 510(k) Cleared K263120 Oct 2, 2026 28d
Roche Diagnostics
 Elecsys EBV IgM Diagnostics 510(k) Cleared K260233 Oct 2, 2026 249d
LivaNova USA, Inc.
 VNS Therapy® System Neurology PMA Supplement Approved P970003/S254 Oct 2, 2026 203d
Medtronic, Inc.
 Sphere-9 Catheter and Affera Ablation System Cardiovascular PMA Supplement Approved P240013/S031 Oct 2, 2026 35d
Motiva USA, LLC
 Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants … Surgical PMA Supplement Approved P230005/S002 Oct 2, 2026 484d
ZOLL Medical Corporation
 X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode … Cardiovascular PMA Supplement Approved (30-day notice) P160022/S054 Oct 2, 2026 28d
Boston Scientific Corporation
 EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) high voltage (HV) Capacitor Cardiovascular PMA Supplement Approved (30-day notice) P110042/S216 Oct 2, 2026 22d
Abbott
 CentriMag™ Circulatory Support System Cardiovascular PMA Supplement Approved (30-day notice) P170038/S033 Oct 2, 2026 24d
Medibeacon, Inc.
 MediBeacon Transdermal GFR System Other PMA Supplement Approved P230019/S005 Oct 2, 2026 15d
Farapulse, Inc.
 FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter … Cardiovascular PMA Supplement Approved (30-day notice) P230030/S025 Oct 2, 2026 18d
Centerline Biomedical
 Intra-Operative Positioning System (IOPS) and IOPS Visionary System Cardiovascular 510(k) Cleared K263016 Oct 1, 2026 34d
FDC Technology Industry Co.
 Firstar Dental Handpieces Dental 510(k) Cleared K260029 Oct 1, 2026 269d
Shenzhen Brav Electronic Technologies Co., Ltd.
 Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C … Cardiovascular 510(k) Cleared K260470 Oct 1, 2026 231d
Yty Industry (Manjung) Sdn Bhd
 Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential … General Hospital 510(k) Cleared K262208 Oct 1, 2026 93d
Microport Orthopedics, Inc.
 NEXUS® Hip Stem Orthopedic 510(k) Cleared K262473 Oct 1, 2026 76d
Sorin Group Italia S.R.L.
 Dual Stage Venous Cannulae Cardiovascular 510(k) Cleared K263092 Oct 1, 2026 28d
Tdm Co., Ltd.
 NOVIX Pedicle Screw System Orthopedic 510(k) Cleared K263062 Oct 1, 2026 30d
bioMerieux, Inc.
 VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) Diagnostics 510(k) Cleared K260283 Oct 1, 2026 245d
FDC Technology Industry Co.
 Firstar Dental Electric Motor Dental 510(k) Cleared K260027 Oct 1, 2026 269d
Airs Medical, Inc.
 SwiftSight-BodyComposition Imaging 510(k) Cleared K261612 Oct 1, 2026 139d
Abbott Medical
 HeartMate II LVAS Cardiovascular PMA Supplement Approved (30-day notice) P060040/S128 Oct 1, 2026 28d
Edwards Lifesciences, LLC
 Autus Size-Adjustable Valve Cardiovascular PMA Approved P260007 Oct 1, 2026 234d
Berlin Heart, Inc.
 EXCOR Pediatric Ventricular Assist Device Cardiovascular PMA Supplement Approved P160035/S057 Oct 1, 2026 212d
Abbott Vascular
 XIENCE PRO5 Everolimus Eluting Coronary Stent System (XIENCE PRO5) … Cardiovascular PMA Supplement Approved (30-day notice) P110019/S145 Oct 1, 2026 30d
Pramand, LLC
 CraniSeal™ Dural Sealant Neurology PMA Supplement Approved P220014/S013 Oct 1, 2026 30d
Abbott Medical
 HeartMate 3 LVAS Cardiovascular PMA Supplement Approved (30-day notice) P160054/S135 Oct 1, 2026 28d
Alcon Research, Ltd.
 PROVISC™ Ophthalmic Viscosurgical Device Ophthalmic PMA Supplement Approved (30-day notice) P890047/S072 Oct 1, 2026 29d
Glaukos Corporation
 Glaukos® iStent inject® W Trabecular Micro-Bypass System … Ophthalmic PMA Supplement Approved (30-day notice) P170043/S023 Oct 1, 2026 30d
Alcon Laboratories
 VISCOAT™ Ophthalmic Viscosurgical Device; DUOVISC™ Ophthalmic Viscosurgical System … Ophthalmic PMA Supplement Approved (30-day notice) P840064/S094 Oct 1, 2026 29d
CyDen Limited
 Braun Aura 7 (6041) Surgical 510(k) Cleared K261975 Sep 30, 2026 110d
Fussen Technology Co., Ltd.
 Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) Imaging 510(k) Cleared K263033 Sep 30, 2026 30d
Brainlab SE
 Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine Neurology 510(k) Cleared K262257 Sep 30, 2026 90d
Qpix Solutions, Inc.
 EzSensor HD Dental 510(k) Cleared K261663 Sep 30, 2026 133d
Danumed Medizintechnik GmbH
 danumed StomaMeter Other 510(k) Cleared K262038 Sep 30, 2026 105d
Duet Spine Holdings, LLC
 Duet™ Spinal Fixation System Orthopedic 510(k) Cleared K262712 Sep 30, 2026 61d
Centers for Disease Control and Prevention
 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit … Diagnostics 510(k) Cleared K263035 Sep 30, 2026 30d
Mui Scientific, Inc.
 Rapid Barostat Bag (RBB) Pump and Catheter System Other 510(k) Cleared K262621 Sep 30, 2026 64d
Spinal Alignment Solutions, Inc.
 SAS MIS Pelvic Incidence Rods Orthopedic 510(k) Cleared K263172 Sep 30, 2026 20d
Barco N.V.
 Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where “x” may be any numeric character). Cardiovascular 510(k) Cleared K261469 Sep 30, 2026 149d
Medical AI Co., Ltd.
 ECG Analysis Software (AiTiALVSD) Cardiovascular 510(k) Cleared K254302 Sep 30, 2026 273d
Revvity, Inc.
 Eonis™ SMA kit Diagnostics 510(k) Cleared K262893 Sep 30, 2026 44d
Elos Medtech Pinol A/S
 Elos Accurate Hybrid Base Dental 510(k) Cleared K261327 Sep 30, 2026 161d
Alcon Research, LLC
 UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System Ophthalmic PMA Supplement Approved (30-day notice) P220030/S012 Sep 30, 2026 30d
Bausch & Lomb, Inc.
 enVista® Hydrophobic Acrylic Intraocular Lens Ophthalmic PMA Supplement Approved (30-day notice) P910056/S064 Sep 30, 2026 28d
Abbott Medical
 CardioMEMS PA Sensor and Delivery System Cardiovascular PMA Supplement Approved (30-day notice) P100045/S093 Sep 30, 2026 27d
Abbott Medical
 CardioMEMS HF System; Merlin.net PCN HF Portal (Model MN6000) … Cardiovascular PMA Supplement Approved P100045/S091 Sep 30, 2026 90d
Bausch & Lomb, Inc.
 enVista Envy™ Hydrophobic Acrylic Intraocular Lens Ophthalmic PMA Supplement Approved (30-day notice) P240005/S008 Sep 30, 2026 28d
Alcon Research, LLC
 UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System Ophthalmic PMA Supplement Approved (30-day notice) P230012/S012 Sep 30, 2026 30d
Medtronic, Inc.
 Harmony TPV System Cardiovascular PMA Supplement Approved (30-day notice) P200046/S052 Sep 30, 2026 14d
Medyssey Co., Ltd.
 NeckTune™ SA Cervical Cage Orthopedic 510(k) Cleared K262726 Sep 29, 2026 60d
Xuzhou Heabens Medical Technology Co., Ltd.
 Electric Wheelchair (0080) Physical Medicine 510(k) Cleared K262241 Sep 29, 2026 90d
Nanjing Mijo Technology Co., Ltd.
 Power Mobility Scooter (MA03) Physical Medicine 510(k) Cleared K262213 Sep 29, 2026 91d
Zhejiang Kailang Technology Co., Ltd.
 Mobility Scooter (Yq-401,Yq- 401A,Yq-403,Yq-403A) Physical Medicine 510(k) Cleared K262553 Sep 29, 2026 67d
BridgeSource Medical Corporation
 SmartRead(TM) Medical Device Identifier (4100) Cardiovascular De Novo Granted DEN260007 Sep 29, 2026 189d
Djo, LLC
 Spinalogic Bone Growth Stimulator Orthopedic 510(k) Cleared K262721 Sep 29, 2026 60d
QT Medical, Inc.
 QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) Cardiovascular 510(k) Cleared K260250 Sep 29, 2026 245d
Cascination AG
 CAS-One IR Imaging 510(k) Cleared K261225 Sep 29, 2026 167d
Elucid Bioimaging, Inc.
 Elucid FFR-IQ (B.1) Cardiovascular 510(k) Cleared K262015 Sep 29, 2026 106d
Pro3Dure Medical GmbH
 Thermeo® I Msi Other 510(k) Cleared K260031 Sep 29, 2026 266d
Siemens Healthineers AG
 Syngo Carbon Space (VA4) Imaging 510(k) Cleared K263048 Sep 29, 2026 29d
Riverpoint Medical, LLC
 Fast Absorbing PGLA Surgical 510(k) Cleared K263073 Sep 29, 2026 28d
C.R. Bard, Inc.
 Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web Webber Surgical PMA Supplement Approved (30-day notice) P800002/S036 Sep 29, 2026 25d
Bausch & Lomb, Inc.
 enVista Aspire™ Hydrophobic Acrylic Intraocular Lens (IOL) Ophthalmic PMA Supplement Approved (30-day notice) P910056/S065 Sep 29, 2026 25d
Allergan
 Natrelle Silicone-Filled Breast Implants and Natrelle INSPIRA Silicone-Filled Breast Implants Surgical PMA Supplement Approved P020056/S064 Sep 29, 2026 747d
Medtronic Minimed, Inc.
 MiniMed 780G System Diagnostics PMA Supplement Approved P160017/S140 Sep 29, 2026 28d
Zoll Manufacturing Corporation
 LifeVest® Wearable Defibrillator Cardiovascular PMA Supplement Approved (30-day notice) P010030/S203 Sep 29, 2026 27d
Newclip Technics
 Alians Forearm Orthopedic 510(k) Cleared K262649 Sep 28, 2026 60d
TELA Bio, Inc.
 Liora Monofilament Scaffold Surgical 510(k) Cleared K260474 Sep 28, 2026 228d
Davol, Inc., A Subsidiary of C.R. Bard, Inc.
 Phasix ST Parastomal Hernia Mesh Surgical 510(k) Cleared K261543 Sep 28, 2026 143d
Biomérieux, Inc.
 VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL) Diagnostics 510(k) Cleared K260619 Sep 28, 2026 215d
Sorin Group Italia S.R.L.
 Tri Stage Venous Cannulae Cardiovascular 510(k) Cleared K262052 Sep 28, 2026 102d
Cochlear Americas
 Nucleus® 24 Cochlear Implant System Other PMA Supplement Approved (30-day notice) P970051/S244 Sep 28, 2026 28d
Cochlear Americas
 Cochlear Hybrid Implant System Other PMA Supplement Approved (30-day notice) P130016/S061 Sep 28, 2026 28d
Cochlear Americas
 Cochlear Auditory Brainstem Implant System Other PMA Supplement Approved (30-day notice) P000015/S057 Sep 28, 2026 28d
Bunnell, Inc.
 LifePulse® High Frequency Ventilator Anesthesiology PMA Supplement Approved P850064/S056 Sep 28, 2026 537d
Kestra Medical Technologies, Inc.
 ASSURE Wearable Cardioverter Defibrillator (WCD) System Cardiovascular PMA Supplement Approved (30-day notice) P200037/S021 Sep 28, 2026 28d
Rejoni, Inc.
 Juveena Hydrogel System Women's Health PMA Approved P250051 Sep 28, 2026 292d
Cochlear Americas
 Nucleus® 22 Cochlear Implant System Other PMA Supplement Approved (30-day notice) P840024/S099 Sep 28, 2026 28d
Cochlear Americas
 Nucleus® 22 Cochlear Implant System Other PMA Supplement Approved (30-day notice) P890027/S067 Sep 28, 2026 28d
Rivarp Medical Pvt., Ltd.
 Kentrospine Viktr-MIS® Pedicle screw system Orthopedic 510(k) Cleared K252139 Sep 27, 2026 446d
Fit-Pro KFT (Ltd.) - DBA E-Fit
 Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set) … Other 510(k) Cleared K260945 Sep 27, 2026 188d
Solventum US, LLC
 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) General Hospital 510(k) Cleared K261992 Sep 25, 2026 102d
Hyundai Bioland Co., Ltd.
 Rebohil (Bgm-1, Bgm-2, Bgm-3, Bgm-4, Bgm-5) Dental 510(k) Cleared K254210 Sep 25, 2026 270d
Cyden Limited
 Braun Aura 9 (6042) Surgical 510(k) Cleared K261977 Sep 25, 2026 105d
CMT Health PTE., Ltd.
 Profoject™ LOR Syringe Anesthesiology 510(k) Cleared K261372 Sep 25, 2026 151d
Cepheid
 Xpert Respiratory Panel Diagnostics 510(k) Cleared K261336 Sep 25, 2026 155d
Life Detection Technologies
 DistaSense(TM) (v1) Cardiovascular 510(k) Cleared K254058 Sep 25, 2026 282d
CMT Health PTE., Ltd.
 Profoject™ Safety Sliding Blood Collection Set Diagnostics 510(k) Cleared K262215 Sep 25, 2026 87d
Ezisurg Medical Co., Ltd.
 easyEndo™ E-Lite Single Use Powered Endoscopic Staplers … Surgical 510(k) Cleared K254291 Sep 25, 2026 268d
SimBioSys, Inc.
 TumorSight Risk Diagnostics 510(k) Cleared K260023 Sep 25, 2026 263d
Arthrex, Inc.
 Arthrex Beaming System Orthopedic 510(k) Cleared K262975 Sep 25, 2026 30d
Aevice Health Pte. , Ltd.
 Aevice Wheeze Detection Module Anesthesiology 510(k) Cleared K260140 Sep 25, 2026 248d
CapsoVision, Inc.
 CapsoView (CVV); CapsoCloud (CLD) Other 510(k) Cleared K254230 Sep 25, 2026 270d
Spident Co., Ltd.
 EsTemp Implant Dental 510(k) Cleared K262983 Sep 25, 2026 29d
Respironics, Inc.
 Altis Full Face Mask Anesthesiology 510(k) Cleared K261262 Sep 25, 2026 162d
Samsung Medison Co., Ltd.
 EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System … Imaging 510(k) Cleared K263182 Sep 25, 2026 14d
Align Technology, Inc.
 Invisalign System Dental 510(k) Cleared K262196 Sep 25, 2026 88d
Karl Storz SE & CO. KG
 UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver … Women's Health 510(k) Cleared K254252 Sep 25, 2026 270d
Philips Ultrasound, LLC
 EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System Imaging 510(k) Cleared K262548 Sep 25, 2026 64d
Wellysis Corp.
 S-Patch CardioAI Cardiovascular 510(k) Cleared K254255 Sep 25, 2026 270d
Siemens Medical Solutions USA, Inc.
 syngo.CT Brain Quantification Imaging 510(k) Cleared K260055 Sep 25, 2026 260d
Tempus AI, Inc.
 Tempus ECG-MR Cardiovascular 510(k) Cleared K254297 Sep 25, 2026 268d
Medtronic Cryocath, LP
 STOP Persistent AF Cardiovascular PMA Supplement Approved P100010/S154 Sep 25, 2026 210d
Biotronik, Inc.
 Edora 8 HF-T QP 407137 Edora 8 HF-T 407138 Evity 8 HF-T QP 407139 Evity 8 HF-T 407140 Enitra 8 HF-T QP 407141 … Cardiovascular PMA Supplement Approved P070008/S172 Sep 25, 2026 365d
Lungpacer Medical USA, Inc.
 AeroPace® System Anesthesiology PMA Supplement Approved P240012/S008 Sep 25, 2026 86d
Medtronic Cardiac Rhythm Disease Management
 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D Cardiovascular PMA Supplement Approved (30-day notice) P010031/S932 Sep 25, 2026 30d
Biotronik, Inc.
 Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX … Cardiovascular PMA Supplement Approved (30-day notice) P980023/S151 Sep 25, 2026 29d
Biotronik, Inc.
 Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-T, Acticor 7 DR-T, Rivacor 7 DR-T … Cardiovascular PMA Supplement Approved (30-day notice) P000009/S133 Sep 25, 2026 29d
Beaver Visitec International, Inc.
 FINEVISION HP Trifocal IOLs Ophthalmic PMA Supplement Approved P240038/S003 Sep 25, 2026 86d
Biotronik, Inc.
 Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568 Cardiovascular PMA Supplement Approved P000009/S124 Sep 25, 2026 365d
Biotronik, Inc.
 Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149 … Cardiovascular PMA Supplement Approved P950037/S279 Sep 25, 2026 365d
Motiva USA, LLC
 Motiva SmoothSilk® Round and Round Ergonomix® Silicone Gel-Filled Breast Implants Surgical PMA Supplement Approved P230005/S005 Sep 25, 2026 176d
Bard Peripheral Vascular, Inc.
 Liverty™ TIPS Stent Graft Cardiovascular PMA Approved P250050 Sep 25, 2026 303d
Medtronic Cardiac Rhythm Disease Management
 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD Cardiovascular PMA Supplement Approved (30-day notice) P980016/S965 Sep 25, 2026 30d
Biotronik, Inc.
 Acticor Sky HF-T, Rivacor Sky HF-T, Rivacor Rise HF-T, Rivacor Aura HF-T, Acticor Sky HF-T QP … Cardiovascular PMA Supplement Approved (30-day notice) P050023/S214 Sep 25, 2026 29d
Biotronik, Inc.
 Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625 … Cardiovascular PMA Supplement Approved P050023/S204 Sep 25, 2026 365d
Depuy, Inc.
 LCS® Total Knee System Orthopedic PMA Supplement Approved (30-day notice) P830055/S375 Sep 25, 2026 24d
Biotronik, Inc.
 Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569 Cardiovascular PMA Supplement Approved P980023/S140 Sep 25, 2026 365d
Endotronix, Inc.
 Cordella Pulmonary Artery Sensor System (CorPASS) Cardiovascular PMA Supplement Approved (30-day notice) P230040/S033 Sep 25, 2026 23d
Karl Storz SE & CO. KG
 Karl Storz Supraloop Women's Health 510(k) Cleared K254303 Sep 24, 2026 267d
Carlsmed, Inc.
 corra® cervical plating system Orthopedic 510(k) Cleared K262149 Sep 24, 2026 91d
Zimmer, Inc.
 OsseoFit Stemless Shoulder System Orthopedic 510(k) Cleared K262955 Sep 24, 2026 31d
CNSAC Medshop GmbH
 Disposable Belts for Polysomnography (CNSAC) Anesthesiology 510(k) Cleared K260949 Sep 24, 2026 185d
OrthoPediatrics Corp.
 Pediatric Nailing Platform Femur Orthopedic 510(k) Cleared K261345 Sep 24, 2026 154d
QIAGEN GmbH
 QIAstat-Dx BCID GN Plus AMR Panel Diagnostics 510(k) Cleared K262168 Sep 24, 2026 90d
Shenzhen Nuon Medical Equipment Co., Ltd.
 Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60) Physical Medicine 510(k) Cleared K262183 Sep 24, 2026 87d
Den-Mat Holdings, LLC
 MPa Max adhesive Dental 510(k) Cleared K262252 Sep 24, 2026 84d
Diagnostica Stago, Inc.
 STA® - Liquid Anti-Xa Diagnostics 510(k) Cleared K260214 Sep 24, 2026 244d
Arthrex, Inc.
 Arthrex Spine Compression FT Screw Other 510(k) Cleared K262618 Sep 24, 2026 58d
MEDA Co., Ltd.
 MD-6000S Bladder Scanner Imaging 510(k) Cleared K260313 Sep 24, 2026 237d
Anhui Jbh Medical Apparatus Co., Ltd.
 Electric Scooter (FNS01,FNS03) Physical Medicine 510(k) Cleared K261078 Sep 24, 2026 176d
BLUECORE COMPANY Co., Ltd.
 PicoreMax (PicoreMax) Surgical 510(k) Cleared K254199 Sep 24, 2026 269d
inomed Medizintechnik GmbH
 ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress Neurology 510(k) Cleared K263010 Sep 24, 2026 27d
CIVCO Medical Instruments Co., Inc.
 Align® Cover and Pad Guidance Tool Imaging 510(k) Cleared K260114 Sep 24, 2026 253d
DiaSorin, Inc.
 LIAISON® QuantiFERON®-TB Gold Plus II. Diagnostics PMA Supplement Approved (30-day notice) P180047/S046 Sep 24, 2026 23d
Abbott Medical
 Esprit™ BTK Everolimus Eluting Resorbable Scaffold System Cardiovascular PMA Supplement Approved P230036/S020 Sep 24, 2026 30d
Medtronic Neuromodulation
 Vanta™with AdaptiveStim™ Technology - Model 977006 Neurology PMA Supplement Approved (30-day notice) P840001/S634 Sep 24, 2026 27d
Biotronik AG
 ORSIRO Sirolimus Eluting Coronary Stent System Cardiovascular PMA Supplement Approved (30-day notice) P170030/S066 Sep 24, 2026 30d
Physio-Control, Inc.
 Lifepak 1000 Defibrillator, Lifepak 20 Defibrillator/ Monitor, Lifepak 20E Defibrillator/ Monitor … Cardiovascular PMA Supplement Approved (30-day notice) P160026/S074 Sep 24, 2026 22d
Impulse Dynamics (Usa), Inc.
 OPTIMIZER Smart System Cardiovascular PMA Supplement Approved P180036/S044 Sep 24, 2026 90d
AtriCure, Inc.
 Synergy Ablation System Cardiovascular PMA Supplement Approved (30-day notice) P100046/S021 Sep 24, 2026 30d
Rayner Intraocular Lenses , Ltd.
 RayOne Galaxy; Model RAO605G, RayOne Galaxy Toric; Model RAO615X Ophthalmic PMA Supplement Approved P060011/S045 Sep 24, 2026 224d
Zimmer, Inc.
 NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee System Orthopedic PMA Supplement Approved (30-day notice) P060037/S099 Sep 24, 2026 9d
Medtronic, Inc.
 Medtronic Activa Tremor Control System Neurology PMA Supplement Approved (30-day notice) P960009/S546 Sep 24, 2026 27d
Abbott Vascular, Inc.
 Perclose ProGlide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair System Cardiovascular PMA Supplement Approved (30-day notice) P960043/S137 Sep 24, 2026 29d
AtriCure, Inc.
 EPi- Sense ST Coagulation System Cardiovascular PMA Supplement Approved (30-day notice) P200002/S015 Sep 24, 2026 30d
Medtronic, Inc.
 IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Cardiovascular PMA Supplement Approved (30-day notice) P140010/S106 Sep 24, 2026 20d
Proverum, Ltd.
 ProVee System for BPH Other PMA Supplement Approved P250011/S006 Sep 24, 2026 30d
Costa Surgical, Inc.
 ProRib Fixation System Orthopedic 510(k) Cleared K261892 Sep 23, 2026 110d
ProNova Solutions
 Virtue Qa Imaging 510(k) Cleared K260597 Sep 23, 2026 211d
BTL Industries, Inc.
 Btl-299-F Other 510(k) Cleared K262353 Sep 23, 2026 75d
Zimmer Biomet
 G7® Acetabular System Orthopedic 510(k) Cleared K261453 Sep 23, 2026 145d
Elevation Spine
 SABER-C System Orthopedic 510(k) Cleared K263049 Sep 23, 2026 23d
Unidental Co., Ltd.
 Cemented Plus Abutment Dental 510(k) Cleared K262207 Sep 23, 2026 85d
SI-BONE, Inc.
 iFuse Granite Onyx™ Implant System Orthopedic 510(k) Cleared K262067 Sep 23, 2026 93d
SETAGAYA SEIKI Co., Ltd.
 DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece Dental 510(k) Cleared K262144 Sep 23, 2026 90d
Abbott Laboratories
 Anti-HCV Next Diagnostics 510(k) Cleared K262156 Sep 23, 2026 89d
Teleflex Medical
 Liquick X-treme, Liquick X-treme Plus Other 510(k) Cleared K261418 Sep 23, 2026 146d
Oxytek Medical Technology Co., Ltd.
 Portable Oxygen Concentrator (OX-1A-E, OX-1B) Anesthesiology 510(k) Cleared K254289 Sep 23, 2026 266d
Suzhou Green Pine Medical Co., Ltd.
 Electric wheelchair (GP100) Physical Medicine 510(k) Cleared K262582 Sep 23, 2026 58d
MedShape, Inc.
 DynaNail Helix® Fixation System Orthopedic 510(k) Cleared K260995 Sep 23, 2026 181d
Guangdong Ashmore Health Technology Co., Ltd.
 Hair Growth Comb (X-GC01) Physical Medicine 510(k) Cleared K262254 Sep 23, 2026 83d
Special Situations, LLC
 Everslide Women's Health 510(k) Cleared K260117 Sep 23, 2026 252d
Hunan Vathin Medical Instrument Co., Ltd.
 Single-use Flexible Bronchoscope Other 510(k) Cleared K261637 Sep 23, 2026 128d
Syneris
 Syneris PACS v.1.0.1.0 Imaging 510(k) Cleared K261874 Sep 23, 2026 110d
Edwards Lifesciences, LLC
 Edwards Crimper (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29) Cardiovascular PMA Supplement Approved (30-day notice) P200015/S083 Sep 23, 2026 29d
Intersect Ent.
 Propel Family Products Other PMA Supplement Approved P100044/S060 Sep 23, 2026 89d
Abbott Medical
 Infinity DBS IPG Neurology PMA Supplement Approved P140009/S139 Sep 23, 2026 86d
Edwards Lifesciences, LLC
 Edwards Crimper (9600LDS23, 9600LDS26, 9600LDS29, 9750CM20, 9750CM23, 9750CM26, 9750CM29) Cardiovascular PMA Supplement Approved (30-day notice) P140031/S209 Sep 23, 2026 29d
Allurion Technologies, Inc.
 Allurion™ Gastric Balloon System Other PMA Supplement Approved P250023/S002 Sep 23, 2026 30d
Abbott Medical
 Proclaim DRG IPG Neurology PMA Supplement Approved P150004/S100 Sep 23, 2026 86d
Abbott Medical
 Proclaim family of SCS IPG Neurology PMA Supplement Approved P010032/S260 Sep 23, 2026 86d
Medtronic
 HeartWare® HVAD System Cardiovascular PMA Supplement Approved P100047/S241 Sep 23, 2026 28d
Edwards Lifesciences, LLC
 PASCAL Ace with Capture Clarity™ Valve Repair System – MR Implant System Cardiovascular PMA Supplement Approved P220003/S028 Sep 23, 2026 180d
ACTO GmbH
 Actolind® (06.3637. Actolind® Gel Plus) Other 510(k) Cleared K254168 Sep 22, 2026 273d
Alfa Scientific Designs, Inc.
 Instant-View® hCG Combo II Cassette Test Diagnostics 510(k) Cleared K262299 Sep 22, 2026 77d
Bh Group Us, LLC
 Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) Surgical 510(k) Cleared K243223 Sep 22, 2026 715d
Neko Health AB
 Echo-2 Cardiovascular 510(k) Cleared K254240 Sep 22, 2026 267d
Samsung HME America, Inc., dba NeuroLogica Corp.
 BodyTom 64 (NL4100); OmniTom Elite (NL5000) Imaging 510(k) Cleared K261125 Sep 22, 2026 169d
Visiana
 BoneXpert Imaging 510(k) Cleared K262390 Sep 22, 2026 71d
Replasia BV
 HipStudio Analysis Imaging 510(k) Cleared K262442 Sep 22, 2026 68d
Strongback Mobility AG C/O Blueaudit GmbH
 ErgoSteel (ES0001/696) Physical Medicine 510(k) Cleared K253762 Sep 22, 2026 301d
Biofire Diagnostics
 BIOFIRE Respiratory Panel 2.1 (RP2.1) Diagnostics 510(k) Cleared K263054 Sep 22, 2026 21d
Siemens Medical Solutions Diagnostics Limited
 IMMULITE Systems Free PSA Diagnostics PMA Supplement Approved (30-day notice) P060005/S027 Sep 22, 2026 28d
Boston Scientific Corp
 Precision Spectra SCS Systems; Precision Novi SCS Systems; Precision Montage MRI SCS Systems … Neurology PMA Supplement Approved P030017/S399 Sep 22, 2026 68d
Siemens Healthcare Diagnostics, Inc.
 IMMULITE Systems AFP Diagnostics PMA Supplement Approved (30-day notice) P010007/S028 Sep 22, 2026 28d
Boston Scientific Corp
 Vercise Genus DBS Systems; Vercise Gevia DBS Systems Neurology PMA Supplement Approved P150031/S098 Sep 22, 2026 68d
Siemens Healthcare Diagnostics, Inc.
 IMMULITE Systems PSA Diagnostics PMA Supplement Approved (30-day notice) P930027/S041 Sep 22, 2026 28d
Abbott Medical
 TactiFlex™ Ablation Catheter, Sensor Enabled™ Cardiovascular PMA Supplement Approved P220013/S034 Sep 22, 2026 43d
Spineart USA, Inc.
 BAGUERA®C Cervical Disc Prosthesis Orthopedic PMA Supplement Approved P250042/S002 Sep 22, 2026 27d
Intersect Ent.
 Propel Other PMA Supplement Approved (30-day notice) P100044/S061 Sep 22, 2026 29d
Ironsides Medical, Inc.
 OtoCompanion (Version 1.0) Other 510(k) Cleared K261725 Sep 21, 2026 118d
Ischemaview, Inc.
 Rapid Platform (R6.7) Imaging 510(k) Cleared K261368 Sep 21, 2026 147d
ZimVie US Corp, LLC
 BellaTek Bars Dental 510(k) Cleared K260940 Sep 21, 2026 185d
KALR STORZ SE & Co. KG
 KARL STORZ TIPCAM1 Rubina Other 510(k) Cleared K262547 Sep 21, 2026 60d
Trisalus Life Sciences
 TriSalus TriNav Advance Infusion System Cardiovascular 510(k) Cleared K253509 Sep 21, 2026 320d
Shanghai Personage Hygiene Products Co., Ltd.
 FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain) … Women's Health 510(k) Cleared K262108 Sep 21, 2026 90d
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
 Disposable Ureteral Access Sheath Other 510(k) Cleared K260512 Sep 21, 2026 216d
Zylox Medtech Co., Ltd.
 ZYLOX Hippo PTA Balloon Dilatation Catheter Cardiovascular 510(k) Cleared K260416 Sep 21, 2026 224d
Spident Co., Ltd.
 Core·it Dual Dental 510(k) Cleared K262982 Sep 21, 2026 25d
Steps Ortho
 F.A.S.T Screw Orthopedic 510(k) Cleared K254280 Sep 21, 2026 265d
Beckman Coulter, Inc.
 Access NT-proBNP Diagnostics 510(k) Cleared K262109 Sep 21, 2026 90d
Depuy, Inc.
 Attune Revision Knee System Orthopedic PMA Supplement Approved P830055/S351 Sep 21, 2026 360d
Agilent Technologies Singapore (International) Pte , Ltd.
 HercepTest™ Diagnostics PMA Supplement Approved (30-day notice) P980018/S027 Sep 21, 2026 63d
Agilent Technologies, Inc.
 PD-L1 IHC 28-8 pharmDx Diagnostics PMA Supplement Approved (30-day notice) P150025/S019 Sep 21, 2026 63d
Endospan , Ltd.
 NEXUS Aortic Arch Stent Graft System Cardiovascular PMA Supplement Approved P250033/S004 Sep 21, 2026 90d
Agilent Technologies, Inc.
 PD-L1 IHC 22C3 pharmDx Diagnostics PMA Supplement Approved (30-day notice) P150013/S034 Sep 21, 2026 63d
Agilent Technologies, Inc.
 MAGE-A4 IHC 1F9 pharmDx Diagnostics PMA Supplement Approved (30-day notice) P230016/S004 Sep 21, 2026 63d
Fotona D.O.O.
 Dynamis Pro Family Surgical 510(k) Cleared K252723 Sep 19, 2026 387d
Anhui JBH Medical Apparatus Co., Ltd.
 Electric Scooter (FDB08, FDB08A, FDB12) Physical Medicine 510(k) Cleared K261859 Sep 19, 2026 107d
Lumenis Be, Ltd.
 SmartIPL_NI System Surgical 510(k) Cleared K241973 Sep 19, 2026 806d
ONE BEAUTY Technology Co., Ltd.
 Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B) Surgical 510(k) Cleared K262524 Sep 18, 2026 58d
Fujifilm Corporation
 SCENARIA View Phase 6.0 Imaging 510(k) Cleared K261229 Sep 18, 2026 156d
Karl Storz SE & CO. KG
 UNIDRIVE Select System Women's Health 510(k) Cleared K261102 Sep 18, 2026 168d
Vantis Vascular, Inc.
 CrossFAST Integrated Microcatheter Advanced Delivery System Cardiovascular 510(k) Cleared K262817 Sep 18, 2026 42d
Biolinq Incorporated
 Biolinq Shine Autonomous Time-in-Range Microsensor Diagnostics 510(k) Cleared K262599 Sep 18, 2026 53d
Inari Medical, Inc.
 Triever Duo Catheter Cardiovascular 510(k) Cleared K253419 Sep 18, 2026 352d
Guilin Kevin Peter Technology Co., Ltd.
 Dental Diode Laser Device (Laser-Pen) Surgical 510(k) Cleared K261047 Sep 18, 2026 171d
Nvision Biomedical Technologies
 EnHAnce PEEK Bunion System Orthopedic 510(k) Cleared K262098 Sep 18, 2026 88d
Neptune Medical, Inc.
 Pathfinder Endoscope Overtube Other 510(k) Cleared K262262 Sep 18, 2026 78d
Epic Systems Corporation
 Deterioration Index Version 2 Cardiovascular 510(k) Cleared K260008 Sep 18, 2026 259d
Shenzhen Mericonn Technology Co., Ltd.
 Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) Anesthesiology 510(k) Cleared K254171 Sep 18, 2026 269d
Rapid-Medical , Ltd.
 Hyperdrive 35 Guidewire Cardiovascular 510(k) Cleared K253146 Sep 18, 2026 358d
Elucid Bioimaging, Inc.
 Elucid PlaqueIQ Imaging 510(k) Cleared K261855 Sep 18, 2026 107d
VacHeal, LLC
 VacHeal Negative Pressure Wound Therapy System Surgical 510(k) Cleared K254160 Sep 18, 2026 270d
ICU Medical
 NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) General Hospital 510(k) Cleared K262532 Sep 18, 2026 58d
Canyon Medical, Inc.
 Drainage Catheter Other 510(k) Cleared K254179 Sep 18, 2026 269d
Martech Medical Products
 25G Huber Needle General Hospital 510(k) Cleared K254095 Sep 18, 2026 273d
Hans Biomed Corporation
 MINT MONO Sutures Surgical 510(k) Cleared K254238 Sep 18, 2026 263d
Topcon Corporation
 SLIT LAMP SL-D4 (Type: LED) Ophthalmic 510(k) Cleared K262637 Sep 18, 2026 51d
Integra Lifesciences Corp.
 INTEGRA ® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template … Surgical PMA Supplement Approved (30-day notice) P900033/S117 Sep 18, 2026 28d
Integra Lifesciences Corp.
 CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery Dental PMA Supplement Approved (30-day notice) P840062/S099 Sep 18, 2026 28d
Abbott Medical
 Quattrode®; Octrode™; Penta™; Lamitrode™; Tripole™; TriCentrus™ Lead Extensions Neurology PMA Supplement Approved P010032/S251 Sep 18, 2026 154d
Q-Med AB
 Restylane® Contour Surgical PMA Supplement Approved P140029/S058 Sep 18, 2026 120d
Integra LifeSciences Corporation
 Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent- Fibrillar … Surgical PMA Supplement Approved (30-day notice) P850010/S119 Sep 18, 2026 28d
Abbott Medical
 Epic™ Plus, Epic™ Plus Supra, Epic™ Max, Epic™ Elite, Epic™ Supra G3 Tissue Heart Valves Cardiovascular PMA Supplement Approved (30-day notice) P040021/S063 Sep 18, 2026 31d
Integra LifeSciences Corporation
 Collastat™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent … Surgical PMA Supplement Approved (30-day notice) P810006/S115 Sep 18, 2026 28d
Ferrosan Meidcal Devices A/S
 SURGIFOAM® Absorbable Gelatin Sponge Surgical PMA Supplement Approved P990004/S080 Sep 18, 2026 177d
Guardant Health, Inc.
 Guardant360 CDx Diagnostics PMA Supplement Approved P200010/S029 Sep 18, 2026 190d
Advanced Bionics
 Clarion Multi-Strategy Cochlear Implant Other PMA Supplement Approved P960058/S178 Sep 18, 2026 28d
Novocure, GmbH
 Novocure GmbH’s Optune Gio Neurology PMA Supplement Approved P100034/S045 Sep 18, 2026 123d
MedAlliance, LLC
 SELUTION SLR™ 014 PTCA Drug-Eluting Balloon Cardiovascular PMA Approved P250041 Sep 18, 2026 324d
Foundation Medicine, Inc.
 FoundationOne Liquid CDx (F1LCDx) Diagnostics PMA Supplement Approved (30-day notice) P190032/S032 Sep 18, 2026 30d
Pentamaster Mediq Sdn Bhd
 MOWANA™ Auto Duo General Hospital 510(k) Cleared K261266 Sep 17, 2026 154d
Paragon Implant Mfg., LLC
 TriActive Dental Implant System Dental 510(k) Cleared K261392 Sep 17, 2026 141d
GS Medical Co., Ltd.
 The VEGA Cervical Screw System Orthopedic 510(k) Cleared K254260 Sep 17, 2026 262d
Ethicon Endo-Surgery, LLC
 HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) Surgical 510(k) Cleared K254196 Sep 17, 2026 268d
Stryker Instruments
 Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100) … Surgical 510(k) Cleared K261959 Sep 17, 2026 98d
Abbott Medical
 EnSite™ X EP System Cardiovascular 510(k) Cleared K261729 Sep 17, 2026 114d
Anika Therapeutics, Inc.
 Integrity Retractable Implant Inserter (6000127) Orthopedic 510(k) Cleared K261869 Sep 17, 2026 105d
Menicon Co, Ltd.
 Miru 1day UpSide (midafilcon A) Ophthalmic 510(k) Cleared K262495 Sep 17, 2026 59d
SurGenTec, LLC
 Durashield Device Kit Neurology 510(k) Cleared K252995 Sep 17, 2026 364d
Beijing Nubway S&T Co., Ltd.
 LED Therapy Device (QLXY-01) Surgical 510(k) Cleared K261673 Sep 17, 2026 119d
Medtronic, Inc.
 Protégé™ EverFlex™ Self-expanding Peripheral Stent System Other 510(k) Cleared K262913 Sep 17, 2026 29d
Shenzhen TPH Technology Co., Ltd.
 Wearable Breast Pump (Model S36) Women's Health 510(k) Cleared K254203 Sep 17, 2026 262d
Medacta International S.A.
 M-Vizion Femoral Revision System Extension Orthopedic 510(k) Cleared K260173 Sep 17, 2026 239d
Vcd Medical S.R.L.
 Vessel Closure Device (VCD177213P) Surgical 510(k) Cleared K260677 Sep 17, 2026 199d
Zhengzhou PZ Laser Slim Technology Co., Ltd.
 Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) Surgical 510(k) Cleared K261817 Sep 17, 2026 108d
Dürr Dental SE
 Hygienic Protective Bite Cover (2207-010-50) Surgical 510(k) Cleared K262073 Sep 17, 2026 87d
Ortler Global Tibbi Gerecler Anonim Sirketi
 FRAXION Spinal Fixation System Orthopedic 510(k) Cleared K262091 Sep 17, 2026 87d
Corin, Ltd.
 Unity Total Knee System, Unity Knee Cementless CR Femur Orthopedic 510(k) Cleared K261275 Sep 17, 2026 153d
Biotronik, Inc.
 PSW 2601.U, NEO 2601.U, Acticor Sky HF-T, Rivacor Sky HF-T, Rivacor Rise HF-T, Rivacor Aura HF-T … Cardiovascular PMA Supplement Approved P050023/S211 Sep 17, 2026 155d
Synergy Spine Solutions, Inc.
 Synergy Disc Orthopedic PMA Supplement Approved P250028/S003 Sep 17, 2026 84d
Boston Scientific
 Endotak Lead System Cardiovascular PMA Supplement Approved P910073/S193 Sep 17, 2026 27d
Biotronik, Inc.
 Psw 2601.U, Neo 2601.U Cardiovascular PMA Supplement Approved P070008/S179 Sep 17, 2026 155d
Biotronik, Inc.
 Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX … Cardiovascular PMA Supplement Approved P980023/S146 Sep 17, 2026 155d
Cook, Inc.
 Zenith Fenestrated AAA Endovascular Graft, Zenith Iliac Branch Cardiovascular PMA Supplement Approved (30-day notice) P020018/S070 Sep 17, 2026 28d
Q-Med AB
 SCULPTRA® (injectable poly-L Lactic acid) Surgical PMA Supplement Approved (30-day notice) P030050/S056 Sep 17, 2026 29d
Biotronik, Inc.
 PSW 2601.U, NEO 2601.U, Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-T Cardiovascular PMA Supplement Approved P000009/S130 Sep 17, 2026 155d
Biotronik, Inc.
 PSW 2601.U, NEO 2601.U, Amvia Sky HF-T QP, Amvia Sky HF-T, Amvia Edge HF-T QP, Amvia Sky DR-T, Amvia Sky SR-T … Cardiovascular PMA Supplement Approved P950037/S291 Sep 17, 2026 155d
Yongkang Joymax Medical Technology Co., Ltd.
 Electric Wheelchair Physical Medicine 510(k) Cleared K262054 Sep 16, 2026 90d
DiaDent Group International
 Dia-X Sil Light Body Dental 510(k) Cleared K254152 Sep 16, 2026 268d
Stabilix, LLC
 AerFrame™ Alignment Laser Box (LBV2) Imaging 510(k) Cleared K261865 Sep 16, 2026 104d
Fujifilm Corporation
 APERTO Lucent MRI System Imaging 510(k) Cleared K261283 Sep 16, 2026 152d
DiaDent Group International
 Dia-X Sil Heavy Body Dental 510(k) Cleared K254142 Sep 16, 2026 268d
GE Medical Systems Ultrasound and Primary Care Diagnostics
 EchoPAC Software Only / EchoPAC Plug-in (v211) Imaging 510(k) Cleared K261623 Sep 16, 2026 124d
Traferox Technologies, Inc.
 X°Port Heart Preservation System Other 510(k) Cleared K261913 Sep 16, 2026 100d
Guangdong Newdermo Biotech Co., Ltd.
 LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) Neurology 510(k) Cleared K261370 Sep 16, 2026 142d
Olympus Surgical Technologies America
 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser … Surgical 510(k) Cleared K262877 Sep 16, 2026 30d
Scientia Vascular
 Aristotle 65 Macrowire Cardiovascular 510(k) Cleared K254181 Sep 16, 2026 267d
Amptron Medical, Inc.
 ElintMAX Respiratory Monitor (ElintMAX Monitor A1) Anesthesiology 510(k) Cleared K260226 Sep 16, 2026 233d
ClearClub
 ClearClub Impression Material Dental 510(k) Cleared K261888 Sep 16, 2026 103d
Kossel Medtech (Suzhou) Co., Ltd.
 NC PTA Balloon Dilatation Catheter Cardiovascular 510(k) Cleared K254212 Sep 16, 2026 261d
Ambu A/S
 Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set Other 510(k) Cleared K260309 Sep 16, 2026 229d
Gt Metabolic Solutions, Inc.
 GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) Surgical 510(k) Cleared K261467 Sep 16, 2026 135d
Aspect Imaging, Ltd.
 Embrace Vision Neonatal MRI System Imaging 510(k) Cleared K261758 Sep 16, 2026 111d
A2z Radiology Ai, Inc.
 a2z-Abdo-Triage Imaging 510(k) Cleared K260906 Sep 16, 2026 181d
OrbusNeich Medical (Shenzhen) Co., Ltd.
 JADE SCORE PTA Scoring Balloon Dilatation Catheter Cardiovascular 510(k) Cleared K261778 Sep 16, 2026 110d
Zhenjiang Assure Medical Equipment Co., Ltd.
 Multifunctional wheelchair (YJ-059) Physical Medicine 510(k) Cleared K261919 Sep 16, 2026 99d
ChangSha ChuangDuoLe E-Commerce Co., Ltd.
 Mouth Guard Other 510(k) Cleared K262559 Sep 16, 2026 54d
Ceribell, Inc.
 Ceribell EEG Analysis Software Neurology 510(k) Cleared K261712 Sep 16, 2026 117d
Route 92 Medical, Inc.
 Route 92 Medical Full Length 046 Access System Cardiovascular 510(k) Cleared K260220 Sep 16, 2026 233d
CamDiab
 iOS CamAPS FX Diagnostics 510(k) Cleared K261896 Sep 16, 2026 100d
Ambu A/S
 Ambu® aScope™ Gastro; Ambu® aScope™ Gastro Large Other 510(k) Cleared K261400 Sep 16, 2026 140d
Highridge Medical, LLC
 Mobi-C® Cervical Disc Prosthesis for use at Two Levels Orthopedic PMA Supplement Approved (30-day notice) P110009/S040 Sep 16, 2026 20d
Cerapedics, Inc.
 PearlMatrixTM Peptide Enhanced Bone Graft Orthopedic PMA Supplement Approved (30-day notice) P240001/S003 Sep 16, 2026 23d
Highridge Medical, LLC
 Mobi-C® Cervical Disc Prosthesis for use at One Level Orthopedic PMA Supplement Approved (30-day notice) P110002/S040 Sep 16, 2026 20d
Novocure, GmbH
 Optune HFE Transducer Arrays Neurology PMA Supplement Approved (30-day notice) P100034/S046 Sep 16, 2026 20d
Foundation Medicine, Inc.
 FoundationOne CDx Diagnostics PMA Supplement Approved P170019/S069 Sep 16, 2026 180d
Insightec
 Exablate Model 4000 System Neurology PMA Supplement Approved P150038/S044 Sep 16, 2026 181d
Guardant Health, Inc.
 Shield Other PMA Supplement Approved (30-day notice) P230009/S020 Sep 16, 2026 26d
Xvivo Perfusion, Inc.
 XPS™ with Steen Solution™ Perfusate Other PMA Supplement Approved P180014/S014 Sep 16, 2026 90d
MicroVention, Inc.
 Intraluminal Support Device LVIS/LVIS Jr./LVIS EVO Neurology PMA Supplement Approved (30-day notice) P170013/S013 Sep 16, 2026 28d
Cerapedics, LLC
 i-F ACTOR® Peptide Enhanced Graft Substitute Orthopedic PMA Supplement Approved (30-day notice) P140019/S014 Sep 16, 2026 23d
Mobia Medical, Inc.
 Vivistim® System Physical Medicine PMA Supplement Approved (30-day notice) P210007/S015 Sep 16, 2026 28d
Edwards Lifesciences, LLC
 EVOQUE Tricuspid Valve Replacement System Cardiovascular PMA Supplement Approved P230013/S027 Sep 16, 2026 180d
Mdsim S.A.
 SPINEsim v1.0 Imaging 510(k) Cleared K261861 Sep 15, 2026 103d
Calyxo, Inc.
 CVAC® Aspiration System Other 510(k) Cleared K261447 Sep 15, 2026 137d
Tontarra Medizintechnik GmbH
 Tontarra Punches and Rongeurs Neurology 510(k) Cleared K260446 Sep 15, 2026 216d
Aramis Global AI Consultancies, LLC
 Artificial Intelligence Renal Assessment (AIRA) Version 1 Imaging 510(k) Cleared K261677 Sep 15, 2026 117d
Zhenjiang Assure Medical Equipment Co., Ltd.
 YJ-K1K2 Wheelchair (YJ-013F) Physical Medicine 510(k) Cleared K260145 Sep 15, 2026 238d
Medacta International SA
 GMK Extension Orthopedic 510(k) Cleared K262057 Sep 15, 2026 89d
Karl Storz SE & CO. KG
 CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS) … Other 510(k) Cleared K254299 Sep 15, 2026 258d
Covidien, LLC
 LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated Surgical 510(k) Cleared K261070 Sep 15, 2026 167d
Treace Medical Concepts, Inc.
 TMC Implant Fixation System Orthopedic 510(k) Cleared K262963 Sep 15, 2026 21d
Zhenjiang Assure Medical Equipment Co., Ltd.
 Reclining wheelchair (YJ-013L) Physical Medicine 510(k) Cleared K260144 Sep 15, 2026 238d
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
 Ooopds Imaging 510(k) Cleared K254214 Sep 15, 2026 260d
Zhenjiang Assure Medical Equipment Co., Ltd.
 Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C) Physical Medicine 510(k) Cleared K260141 Sep 15, 2026 238d
Biosense Webster, Inc.
 Qdot Micro Bi-Directional Navigation Catheter; Qdot Micro Uni-Directional Navigation Catheter Cardiovascular PMA Supplement Approved (30-day notice) P210027/S019 Sep 15, 2026 28d
Channel Medsystems, Inc.
 Cerene® Cryotherapy Device Women's Health PMA Supplement Approved (30-day notice) P180032/S024 Sep 15, 2026 28d
Agilent Technologies, Inc.
 MAGE-A4 IHC 1F9 pharmDx Diagnostics PMA Supplement Approved P230016/S003 Sep 15, 2026 110d
Biosense Webster, Inc.
 Varipulse Bi-Directional Catheter Cardiovascular PMA Supplement Approved (30-day notice) P240006/S020 Sep 15, 2026 28d
Biosense Webster, Inc.
 Ez Steer Thermocool Nav Bi-Directional Electrophysiology Catheter … Cardiovascular PMA Supplement Approved (30-day notice) P030031/S146 Sep 15, 2026 28d
Biosense Webster, Inc.
 Thermocool Smarttouch Bi-Directional Navigation Catheter … Cardiovascular PMA Supplement Approved (30-day notice) P040036/S101 Sep 15, 2026 28d
Promega Corporation
 OncoMate® MSI Dx Analysis System Other PMA Approved P250046 Sep 15, 2026 305d
Qure.Ai Technologies Pvt. , Ltd.
 qCT Lung (v1.0) Imaging 510(k) Cleared K261517 Sep 14, 2026 130d
Ovesco Endoscopy AG
 colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) Other 510(k) Cleared K253481 Sep 14, 2026 335d
Horiba ABx SAs
 Yumizen H550 Diagnostics 510(k) Cleared K260781 Sep 14, 2026 188d
Becton Dickinson and Company
 BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth Diagnostics 510(k) Cleared K262163 Sep 14, 2026 80d
Changzhou Sifary Medical Technology Co., Ltd.
 Hand-held Dental X-ray System (HyperLight-M) Dental 510(k) Cleared K260795 Sep 14, 2026 187d
Xenix Medical
 RIVA® Posterior Fixation System with NanoACTIV Surface Technology … Orthopedic 510(k) Cleared K262193 Sep 14, 2026 77d
Eurosets S.R.L
 HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) Cardiovascular 510(k) Cleared K261438 Sep 14, 2026 137d
Maduro Medical, Inc.
 Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit Cardiovascular 510(k) Cleared K261089 Sep 14, 2026 166d
Boston Scientific Corp
 AMS 800™ Artificial Urinary Sphincter (AUS) Other PMA Supplement Approved (30-day notice) P000053/S142 Sep 14, 2026 13d
Medtronic Neuromodulation
 InterStim™ Therapy System, Verify™ Evaluation System Other PMA Supplement Approved (30-day notice) P080025/S352 Sep 14, 2026 25d
Medtronic Neuromodulation
 Altaviva™ Other PMA Supplement Approved (30-day notice) P240011/S016 Sep 14, 2026 25d
Boston Scientific Corp
 AMS 700™ Inflatable Penile Prosthesis (IPP) Other PMA Supplement Approved (30-day notice) N970012/S212 Sep 14, 2026 13d
Medtronic Neuromodulation
 InterStim™ Therapy System Verify™ Evaluation System Other PMA Supplement Approved (30-day notice) P970004/S458 Sep 14, 2026 25d
Bausch and Lomb, Inc.
 Bausch + Lomb Ultra (samfilcon A) Contact Lenses Ophthalmic PMA Supplement Approved (30-day notice) P170035/S021 Sep 14, 2026 28d
Tianjin Huahong Technology Co., Ltd.
 Safety lancet (XL) Surgical 510(k) Cleared K262526 Sep 13, 2026 53d
Boston Scientific Corp
 Vercise Deep Brain Stimulation (Dbs) System Neurology PMA Supplement Approved P150031/S084 Sep 13, 2026 528d
Ascom Ums Srl Unipersonale
 Digistat Care Cardiovascular 510(k) Cleared K261287 Sep 12, 2026 145d
Odin Medical Limited
 Caddie Other 510(k) Cleared K260133 Sep 12, 2026 239d
Curvebeam AI / Curvebeam, LLC
 BoneVue Imaging 510(k) Cleared K254072 Sep 11, 2026 267d
Jeisys Medical Incorporated
 Potenza Prime Surgical 510(k) Cleared K254185 Sep 11, 2026 262d
Baebies, Inc.
 FINDER Flu A&B/SARS-CoV-2 Test Diagnostics 510(k) Cleared K261837 Sep 11, 2026 101d
The General Hospital Corporation, d/b/a Massachusetts
 GSPE Spacer Orthopedic 510(k) Cleared K260063 Sep 11, 2026 246d
SmartWise Sweden AB
 Extroducer Infusion Catheter System Cardiovascular 510(k) Cleared K254051 Sep 11, 2026 268d
Zhejiang Chuangxiang Medical Technology Co., Ltd.
 Single Use Ureteral Access Sheath Other 510(k) Cleared K260410 Sep 11, 2026 214d
Ecomed Solutions, LLC
 Ecomed Disposable Administration Sets General Hospital 510(k) Cleared K254123 Sep 11, 2026 266d
Microstructure Imaging, Inc.
 Micsi-Pet Imaging 510(k) Cleared K261305 Sep 11, 2026 144d
Eizo Corporation
 CuratOR EX2742 Other 510(k) Cleared K262397 Sep 11, 2026 59d
Beta Bionics, Inc.
 Mint ACE Pump Diagnostics 510(k) Cleared K260001 Sep 11, 2026 252d
41Medical AG
 DRIM-Nail System Other 510(k) Cleared K260115 Sep 11, 2026 240d
Heidelberg Engineering GmbH
 Anterion Ophthalmic 510(k) Cleared K261019 Sep 11, 2026 168d
Guizhou Zirui Technology Co., Ltd.
 Disposable Sterile Skull Drill (LZ) Neurology 510(k) Cleared K254177 Sep 11, 2026 262d
Boston Scientific Corporation
 SpaceOAR Flex™ System Imaging 510(k) Cleared K262151 Sep 11, 2026 78d
Magic Science Supply, LLC
 SkinSmart Antimicrobial HydroGel Other 510(k) Cleared K254041 Sep 11, 2026 269d
Zbeats, Inc.
 ZBPro Diagnostic (Version 2.0) Cardiovascular 510(k) Cleared K261580 Sep 11, 2026 121d
Shenzhen Xinyan Medical Technology Co.,ltd.
 Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201) … Cardiovascular 510(k) Cleared K254119 Sep 11, 2026 266d
Vitaltec Corporation
 Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series) … Anesthesiology 510(k) Cleared K253063 Sep 11, 2026 354d
CraniUS, LLC
 CraniUS Plate Neurology 510(k) Cleared K262874 Sep 11, 2026 28d
INNO Holdings Inc. DBA Innovasis
 Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System … Orthopedic 510(k) Cleared K262025 Sep 11, 2026 87d
Kowa Company, Ltd. Chofu Factory
 Kowa Fm-600 Ophthalmic 510(k) Cleared K261255 Sep 11, 2026 148d
Bone Solutions, Inc.
 Mg OSTEOREVIVE™;Mg OSTEOCRETE™ Orthopedic 510(k) Cleared K262230 Sep 11, 2026 73d
PRIMED Medical Products, Inc.
 PRIMED AAMI Level 3 Open Back Gowns Surgical 510(k) Cleared K262007 Sep 11, 2026 88d
Guizhou Zirui Technology Co., Ltd.
 Surgical Power System Neurology 510(k) Cleared K254174 Sep 11, 2026 262d
Xtreem Pulse, LLC
 PureLift Pro Max Neurology 510(k) Cleared K262861 Sep 11, 2026 29d
Beta Bionics, Inc.
 iLet Dosing Decision Software Diagnostics 510(k) Cleared K262763 Sep 11, 2026 38d
Bio Compression Systems, Inc.
 Sequential Circulator (SC-4004-DL, SC-4008-DL) Cardiovascular 510(k) Cleared K261807 Sep 11, 2026 102d
Spident Co., Ltd.
 Vioseal X Dental 510(k) Cleared K262050 Sep 11, 2026 85d
Smith & Nephew Medical, Ltd.
 RENASYS DYNAFLOW Kit (66807741) Surgical 510(k) Cleared K261338 Sep 11, 2026 141d
Agilent Technologies, Inc.
 MMR IHC Panel pharmDx (Dako Omnis) Diagnostics PMA Supplement Approved (30-day notice) P250004/S001 Sep 11, 2026 28d
Biotronik AG
 Astron Peripheral Self-Expanding Nitinol Stent System Cardiovascular PMA Supplement Approved (30-day notice) P140030/S025 Sep 11, 2026 37d
Abbott Medical
 CardioMEMS PA Sensor and Delivery System (CM2000); CardioMEMS™ HF System Cardiovascular PMA Supplement Approved (30-day notice) P100045/S092 Sep 11, 2026 28d
Pulmonx Corporation
 Zephyr Endobronchial Valve System Anesthesiology PMA Supplement Approved P180002/S032 Sep 11, 2026 72d
Biotronik AG
 Pulsar-18 T3 Peripheral Self-Expanding Nitinol Stent System Cardiovascular PMA Supplement Approved (30-day notice) P160025/S026 Sep 11, 2026 37d
Abbott Medical
 Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) Charger Neurology PMA Supplement Approved (30-day notice) P010032/S261 Sep 11, 2026 28d
Agilent Technologies, Inc.
 MAGE-A4 IHC 1F9 pharmDx Diagnostics PMA Supplement Approved (30-day notice) P230016/S005 Sep 11, 2026 28d
Shockwave Medical, Inc.
 Shockwave™ Intravascular Lithotripsy (Ivl) System With Shockwave C2/C2+ Coronary Ivl Catheter Cardiovascular PMA Supplement Approved (30-day notice) P200039/S025 Sep 11, 2026 30d
Pramand, LLC
 SpineSeal™ Spine Sealant Neurology PMA Supplement Approved P240027/S007 Sep 11, 2026 80d
Agilent Technologies, Inc.
 PD-L1 IHC 28-8 pharmDx Diagnostics PMA Supplement Approved (30-day notice) P150025/S020 Sep 11, 2026 28d
Agilent Technologies, Inc.
 Ki-67 IHC MIB-1 pharmDx (Dako Omnis) Diagnostics PMA Supplement Approved (30-day notice) P210026/S003 Sep 11, 2026 28d
Abbott Medical
 Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) Charger Neurology PMA Supplement Approved (30-day notice) P140009/S140 Sep 11, 2026 28d
Agilent Technologies, Inc.
 PD-L1 IHC 22C3 pharmDx Diagnostics PMA Supplement Approved (30-day notice) P150013/S035 Sep 11, 2026 28d
Siemens Medical Solutions USA, Inc.
 ACUNAV Luxera 4D ICE Catheter Cardiovascular 510(k) Cleared K261696 Sep 10, 2026 111d
Wuhan Pioon Technology Co., Ltd.
 Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) Surgical 510(k) Cleared K262426 Sep 10, 2026 56d
Omniscient Neurotechnology Pty, Ltd.
 Quicktome Software Suite Imaging 510(k) Cleared K261795 Sep 10, 2026 104d
Lakong Medical Devices Co., Ltd.
 Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) Dental 510(k) Cleared K254009 Sep 10, 2026 269d
Bioteke Corporation (Wuxi) Co., Ltd.
 BioTeke® Multi-Drug Urine Test Cup Other 510(k) Cleared K261409 Sep 10, 2026 133d
B.Braun Medical, Inc.
 Irrigation/Urology Sets Other 510(k) Cleared K254111 Sep 10, 2026 265d
OMRON Healthcare, Inc.
 Upper Arm Blood pressure monitor (BP7155D) Cardiovascular 510(k) Cleared K261929 Sep 10, 2026 93d
Sanhe LEFIS Electronics Co., Ltd.
 Diode Laser Therapy System Surgical 510(k) Cleared K261562 Sep 10, 2026 122d
Koh Young Technology, Inc.
 Geniant Cranial (Navigated Neurosurgical Positioning Robot) Neurology 510(k) Cleared K253856 Sep 10, 2026 281d
Suzhou Microport Orthorecon Co., Ltd.
 EVOLUTION MPX™ Total Knee System Orthopedic 510(k) Cleared K262293 Sep 10, 2026 65d
Zhejiang Longterm Medical Technology Co., Ltd.
 LT Antibacterial Foam with Silver Dressing Surgical 510(k) Cleared K254246 Sep 10, 2026 255d
Procerus Enterprises
 TruPress Cardiovascular 510(k) Cleared K254074 Sep 10, 2026 266d
Olympus Medical Systems Corp.
 4K Camera Head OLYMPUS CH-S700-08-LB Other 510(k) Cleared K262079 Sep 10, 2026 80d
Invia, LLC
 4DM Imaging 510(k) Cleared K260879 Sep 10, 2026 177d
GC America, Inc.
 Cerasmart Forte Dental 510(k) Cleared K262202 Sep 10, 2026 73d
Danumed Medizintechnik GmbH
 danumed Extension Set for Gastrostomy Button Other 510(k) Cleared K260110 Sep 10, 2026 239d
Biosense Webster, Inc.
 QDOT MICRO™ System Cardiovascular PMA Supplement Approved (30-day notice) P210027/S018 Sep 10, 2026 35d
Biotronik, Inc.
 Pamira S 60; Pamira S 65; Pamira S 75; Pamira SD 60/16; Pamira SD 65/16; Pamira SD 65/18; Pamira SD 75/18 … Cardiovascular PMA Supplement Approved (30-day notice) P980023/S150 Sep 10, 2026 29d
Physio-Control, Inc.
 LIFEPAK® 15 monitor/defibrillator Cardiovascular PMA Supplement Approved (30-day notice) P160026/S073 Sep 10, 2026 28d
Cardiva Medical, Inc.
 VASCADE 5F Vascular Closure System Cardiovascular PMA Supplement Approved (30-day notice) P120016/S043 Sep 10, 2026 29d
Depuy, Inc.
 Attune Rotating Platform (RP) Total Knee System and the DePuy P.F.C.™ Sigma™ Rotating Platform (RP) Total … Orthopedic PMA Supplement Approved (30-day notice) P830055/S376 Sep 10, 2026 6d
Merz North America, Inc.
 Belotero Volume (+) Lidocaine Dermal Filler Surgical PMA Supplement Approved (30-day notice) P250020/S005 Sep 10, 2026 28d
Medtronic, Inc.
 Symplicity Spyral™ Renal Denervation System Cardiovascular PMA Supplement Approved P220026/S014 Sep 10, 2026 225d
Biosense Webster, Inc.
 VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) Cardiovascular PMA Supplement Approved (30-day notice) P240006/S019 Sep 10, 2026 35d
Endoclot Plus Co., Ltd.
 Sis Blu (Sisblu-30-01);Sis Blu (Sisblu-15-01) Other 510(k) Cleared K260997 Sep 9, 2026 167d
Top Glove Sdn. Bhd.
 Biodegradable Nitrile Powder Free Examination Glove, Green … General Hospital 510(k) Cleared K262542 Sep 9, 2026 48d
Argus Cognitive, Inc.
 ReVISION 2 Imaging 510(k) Cleared K251417 Sep 9, 2026 490d
Gleamer
 ChestView US (1.1) Imaging 510(k) Cleared K252486 Sep 9, 2026 398d
E.A.M Benelux B.V
 QF10 Other 510(k) Cleared K261470 Sep 9, 2026 128d
Covalon Technologies, Ltd.
 ColActive Plus Other 510(k) Cleared K260652 Sep 9, 2026 194d
Maxter Healthcare, Inc.
 Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and … General Hospital 510(k) Cleared K261793 Sep 9, 2026 103d
Guangzhou Red Pine Medical Instrument Co., Ltd.
 Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) Other 510(k) Cleared K262488 Sep 9, 2026 51d
Boston Scientific Corp
 WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems; Celestia and Celestia Prime SCS Systems Neurology PMA Supplement Approved P030017/S396 Sep 9, 2026 90d
Abbott Medical
 HeartMate 3™ Left Ventricular Assist System Cardiovascular PMA Supplement Approved (30-day notice) P160054/S134 Sep 9, 2026 30d
Edwards Lifesciences, LLC
 PASCAL Precision Transcatheter Valve Repair System Cardiovascular PMA Supplement Approved (30-day notice) P220003/S033 Sep 9, 2026 22d
Allurion Technologies, Inc.
 Allurion™ Gastric Balloon System Other PMA Supplement Approved P250023/S001 Sep 9, 2026 29d
Centinel Spine, LLC
 prodisc® C Nova Orthopedic PMA Supplement Approved P070001/S031 Sep 9, 2026 120d
Boston Scientific Corporation
 eCoin Peripheral Neurostimulator Other PMA Supplement Approved (30-day notice) P200036/S012 Sep 9, 2026 27d
Depuy, Inc.
 ATTUNE Rotating Platform (RP) Total Knee System, ATTUNE Cementless Rotating Platform (RP) Knee System … Orthopedic PMA Supplement Approved (30-day notice) P830055/S372 Sep 9, 2026 27d
Zoll Manufacturing Corporation
 LifeVest® Wearable Defibrillator Cardiovascular PMA Supplement Approved P010030/S201 Sep 9, 2026 89d
Balt USA, LLC
 SQUID Liquid Embolic Agent (LEA) Neurology PMA Supplement Approved P250009/S002 Sep 9, 2026 86d
Life Technologies Corporation
 Oncomine™ Dx Express Test Diagnostics PMA Supplement Approved P240040/S005 Sep 9, 2026 180d
Premia Spine, Ltd.
 TOPS™ System Orthopedic PMA Supplement Approved (30-day notice) P220002/S011 Sep 9, 2026 30d
B-One Ortho, Corp.
 b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments … Orthopedic 510(k) Cleared K262341 Sep 8, 2026 60d
Osstell AB
 Reusable SmartPeg Dental 510(k) Cleared K261987 Sep 8, 2026 88d
DRTECH Corporation
 EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T) … Imaging 510(k) Cleared K260227 Sep 8, 2026 225d
Shoulder Innovations, Inc.
 N22 Offset Humeral Head Orthopedic 510(k) Cleared K262173 Sep 8, 2026 74d
ANI Co., Ltd.
 Dental Barriers and Sleeves (AB0006) Surgical 510(k) Cleared K261956 Sep 8, 2026 89d
Emboline, Inc.
 Emboliner Embolic Protection System (EPC-03) Cardiovascular 510(k) Cleared K261715 Sep 8, 2026 109d
Intuitive Surgical, Inc.
 da Vinci Surgical System, Model IS5000 Other 510(k) Cleared K261823 Sep 8, 2026 99d
Zhejiang Geyi Medical Instrument Co., Ltd.
 Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30 … Women's Health 510(k) Cleared K254294 Sep 8, 2026 251d
Gmp Medicare Sdn. Bhd.
 Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation … General Hospital 510(k) Cleared K260312 Sep 8, 2026 221d
Yongkang Hengyi Vehicle Co., Ltd.
 Electric wheelchair (HC819N, HC830N, HC831N) Physical Medicine 510(k) Cleared K260229 Sep 8, 2026 225d
Beijing OrionStar Technology Co., Ltd.
 Power Wheelchair (OS-R-M01I) Physical Medicine 510(k) Cleared K260053 Sep 8, 2026 243d
Smith & Nephew, Inc.
 LANDMARK Total Knee System Orthopedic 510(k) Cleared K261462 Sep 8, 2026 127d
Nobel Biocare AB
 LiteSet Trays General Hospital 510(k) Cleared K253988 Sep 8, 2026 270d
DreaMed Diabetes, Ltd.
 MODI System Diagnostics 510(k) Cleared K260062 Sep 8, 2026 243d
Geneoscopy, Inc.
 ColoSense® Diagnostics PMA Supplement Approved P230001/S014 Sep 8, 2026 78d
Vascutek, Ltd.
 Thoraflex™ Hybrid Cardiovascular PMA Supplement Approved P210006/S018 Sep 8, 2026 180d
Medtronic, Inc.
 Micra Functional Testing on pNGHT and NGHT Cardiovascular PMA Supplement Approved (30-day notice) P150033/S230 Sep 8, 2026 27d
Fidelity BioPharma Co.
 KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) Neurology 510(k) Cleared K260396 Sep 6, 2026 212d
Shenzhen Osto Medical Technology Co.,Ltd
 Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J … Neurology 510(k) Cleared K261131 Sep 6, 2026 153d
Cryosurgery, Inc.
 FreezeSpray TA Other 510(k) Cleared K261684 Sep 5, 2026 107d
Nouvag AG
 LipoSurg ARTIST Surgical 510(k) Cleared K254135 Sep 5, 2026 257d
NuSmile, Ltd.
 NeoPEX™ Pre-Mixed Obturation Paste Dental 510(k) Cleared K253909 Sep 4, 2026 270d
Ortho Clinical Diagnostics Inc. (QuidelOrtho)
 Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA Diagnostics 510(k) Cleared K254262 Sep 4, 2026 248d
Piraeus Medical, Inc.
 70 NeuGlide Catheter Cardiovascular 510(k) Cleared K262277 Sep 4, 2026 60d
Fujifilm Corporation
 FCT iStream Phase 2 Imaging 510(k) Cleared K253836 Sep 4, 2026 277d
Medtronic Xomed, Inc.
 ApexCut ™ Blade with Automated EM Tracking (187BL4012EM) … Neurology 510(k) Cleared K262235 Sep 4, 2026 65d
Radiopharmaceutical Imaging & Dosimetry, LLC
 3D-Rd-S Imaging 510(k) Cleared K262060 Sep 4, 2026 78d
Bioretec, Ltd.
 ActivaScrew™ Cannulated COM Orthopedic 510(k) Cleared K261057 Sep 4, 2026 157d
S.M.A.I.O
 KHEIRON® Spinal Fixation System, including patient specific K-ROD Orthopedic 510(k) Cleared K262828 Sep 4, 2026 25d
Sentinel Medical Technologies
 TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) Other 510(k) Cleared K260756 Sep 4, 2026 179d
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
 Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA Diagnostics 510(k) Cleared K254264 Sep 4, 2026 248d
Dentsply Sirona, Inc.
 Surgical and Prosthetic Trays General Hospital 510(k) Cleared K261935 Sep 4, 2026 87d
UAB Telemedicina
 Digital Indeflator INFLANTE Cardiovascular 510(k) Cleared K260035 Sep 4, 2026 241d
Depuy Orthopaedics, Inc.
 ATTUNE Revision Knee System Orthopedic 510(k) Cleared K262130 Sep 4, 2026 72d
Alimetry , Ltd.
 Gastric Alimetry Other 510(k) Cleared K262292 Sep 4, 2026 59d
Siemens Healthcare Diagnostics Products, Ltd.
 IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) Diagnostics 510(k) Cleared K260331 Sep 4, 2026 214d
Peerbridge Health, Inc.
 Peerbridge COR MDx (Cor MDx) Cardiovascular 510(k) Cleared K253529 Sep 4, 2026 295d
MRI2CT, Inc.
 NextMR Spine Imaging 510(k) Cleared K260525 Sep 4, 2026 199d
Guardant Health, Inc.
 Guardant360® CDx Diagnostics PMA Supplement Approved P200010/S024 Sep 4, 2026 463d
Advanced Bionics
 HiResolution Bionic Ear System Other PMA Supplement Approved P960058/S177 Sep 4, 2026 28d
Farapulse, Inc.
 FARASTAR™ Pulsed Field Ablation (PFA) Generator; FARASTAR™ Mapping System Module (MSM) … Cardiovascular PMA Supplement Approved P230030/S024 Sep 4, 2026 66d
Seikagaku Corp.
 Gel-One Orthopedic PMA Supplement Approved P080020/S056 Sep 4, 2026 59d
Abbott Medical
 TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ (A-TFDM-D, A-TFDM-F, A-TFDM-J, A-TFDM-DD, A-TFDM-DF … Cardiovascular PMA Supplement Approved P220013/S028 Sep 4, 2026 186d
Illumina, Inc.
 TruSight Oncology Comprehensive Diagnostics PMA Supplement Approved (30-day notice) P230011/S008 Sep 4, 2026 16d
Seikagaku Corp.
 Supartz Fx Orthopedic PMA Supplement Approved P980044/S067 Sep 4, 2026 60d
LeMaitre Vascular, Inc.
 Artegraft Collagen Vascular Graft Cardiovascular PMA Supplement Approved N16837/S039 Sep 4, 2026 29d
DePuy Orthopaedics, Inc.
 Ceramax Ceramic Hip System Orthopedic PMA Supplement Approved (30-day notice) P070026/S129 Sep 4, 2026 30d
Orthocon, Inc.
 Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT) Other 510(k) Cleared K262769 Sep 3, 2026 30d
Happy Health, Inc.
 Happy Health Blood Pressure Monitor Cardiovascular 510(k) Cleared K254000 Sep 3, 2026 262d
Maxigen Biotech, Inc.
 HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR) … Women's Health 510(k) Cleared K253989 Sep 3, 2026 265d
Marani Health, Inc.
 M•care System (MW-20) Women's Health 510(k) Cleared K253673 Sep 3, 2026 286d
Boston Scientific
 Rezum System Other 510(k) Cleared K262460 Sep 3, 2026 48d
MicroVention, Inc., d/b/a Terumo Neuro
 Mayumi™ Thrombectomy System Cardiovascular 510(k) Cleared K254035 Sep 3, 2026 261d
Neptune Medical, Inc.
 Triton 1 System Other 510(k) Cleared K260503 Sep 3, 2026 198d
Kettenbach GmbH & Co. KG
 Profisil Free Dental 510(k) Cleared K262243 Sep 3, 2026 64d
Endovascular Engineering
 Helo Max Thrombectomy System (HEL2090) Cardiovascular 510(k) Cleared K261800 Sep 3, 2026 94d
Powerful Medical, Inc.
 Queen of Hearts (ACS AI ECG Model) Other De Novo Granted DEN250044 Sep 3, 2026 346d
Philips Consumer Lifestyle B.V.
 Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62) … Women's Health 510(k) Cleared K261622 Sep 3, 2026 111d
Pace Surgical
 Tempo Plating System; Ultra Compression Screw System Orthopedic 510(k) Cleared K261647 Sep 3, 2026 107d
Bryan Medical, Inc.
 Tenax® Laser Resistant Endotracheal Tube Anesthesiology 510(k) Cleared K251794 Sep 3, 2026 448d
Filmecc Co., Ltd.
 CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 Cardiovascular 510(k) Cleared K261281 Sep 3, 2026 139d
Monteris Medical
 NeuroBlate System Surgical 510(k) Cleared K262315 Sep 3, 2026 57d
Bausch & Lomb, Inc.
 enVista hydrophobic acrylic intraocular lens Ophthalmic PMA Supplement Approved (30-day notice) P910056/S063 Sep 3, 2026 24d
Dilon Technologies, Inc.
 HEMOBLAST™ Bellows Surgical PMA Supplement Approved P170012/S032 Sep 3, 2026 66d
Bausch & Lomb, Inc.
 Akreos posterior chamber intraocular lens Ophthalmic PMA Supplement Approved (30-day notice) P060022/S038 Sep 3, 2026 24d
Depuy, Inc.
 LCS(R) TOTAL KNEE SYSTEM, specifically ATTUNE™ Cruciate Retaining (CR) … Orthopedic PMA Supplement Approved (30-day notice) P830055/S374 Sep 3, 2026 6d
Irvine Biomedical,Inc.(Ibi)
 Therapy™ Dual-8™ Ablation Catheter Cardiovascular PMA Supplement Approved (30-day notice) P040042/S060 Sep 3, 2026 27d
Instylla, Inc.
 Embrace Hydrogel Embolic System Cardiovascular PMA Supplement Approved (30-day notice) P250003/S009 Sep 3, 2026 17d
Bausch & Lomb, Inc.
 enVista Envy™ hydrophobic acrylic intraocular lens (IOL) Ophthalmic PMA Supplement Approved (30-day notice) P240005/S007 Sep 3, 2026 24d
Rxsight, Inc.
 RxSight Light Adjustable Lens and Light Delivery Device Ophthalmic PMA Supplement Approved P160055/S056 Sep 3, 2026 87d
Irvine Biomedical, Inc.
 Therapy™ (including Bi-Directional and 4mm Thermistor) Ablation Catheter Cardiovascular PMA Supplement Approved (30-day notice) P040014/S052 Sep 3, 2026 27d
United Orthopedic Corporation
 Momentum Acetabular Cup System Orthopedic 510(k) Cleared K253948 Sep 2, 2026 266d
Ellian Corp
 Ellian Enigma RF Device Surgical 510(k) Cleared K262364 Sep 2, 2026 54d
Trexo Robotics, Inc.
 Trexo Theo Physical Medicine 510(k) Cleared K254198 Sep 2, 2026 253d
Venocare, Inc.
 Ruby Intravascular Catheter General Hospital 510(k) Cleared K260432 Sep 2, 2026 203d
Modular Medical, Inc.
 Pivot Insulin Delivery System General Hospital 510(k) Cleared K262153 Sep 2, 2026 68d
ArthroTAK, LLC
 ArthroTAK Tendon Anchor Kit Orthopedic 510(k) Cleared K262809 Sep 2, 2026 26d
Zhengzhou PZ Laser Slim Technology Co., Ltd.
 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) Surgical 510(k) Cleared K261589 Sep 2, 2026 112d
Cardinalhealth
 Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate General Hospital 510(k) Cleared K261749 Sep 2, 2026 97d
Anika Therapeutics, Inc.
 Hyalomatrix Other 510(k) Cleared K261311 Sep 2, 2026 134d
Aevumed, Inc.
 Aevumed SUPERCYNCH™ Button System Orthopedic 510(k) Cleared K253065 Sep 2, 2026 345d
Flexicare Medical Limited.
 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U) … Other 510(k) Cleared K254026 Sep 2, 2026 260d
GE Medical Systems Ultrasound and Primary Care Diagnostics
 Vivid Explorer/Vivid Advanced/Vivid Focus Imaging 510(k) Cleared K261313 Sep 2, 2026 134d
Serpex Medical
 Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) Surgical 510(k) Cleared K262420 Sep 2, 2026 48d
Hologic, Inc.
 I-View® Imaging 510(k) Cleared K254090 Sep 2, 2026 257d
Vistakon, Division of Johnson & Johnson Vision Car
 Vistakon (Senofilcon A) Contact Lens, Clear And Visibility Tinted With Uv Blocker Ophthalmic PMA Supplement Approved (30-day notice) P040045/S145 Sep 2, 2026 26d
Ferring Pharmaceuticals, Inc.
 EUFLEXXA® (1% sodium hyaluronate) Orthopedic PMA Supplement Approved (30-day notice) P010029/S043 Sep 2, 2026 29d
Biosense Webster, Inc.
 THERMOCOOL SMARTTOUCH® SF Catheter Cardiovascular PMA Supplement Approved P030031/S142 Sep 2, 2026 180d
Tempus AI, Inc.
 xT CDx Diagnostics PMA Supplement Approved P210011/S002 Sep 2, 2026 572d
CooperVision, Inc.
 Biofinity (Comfilcon A) Ophthalmic PMA Supplement Approved (30-day notice) P080011/S204 Sep 2, 2026 26d
Physio-Control, Inc.
 LIFEPAK® 35 monitor/defibrillator Cardiovascular PMA Supplement Approved P160026/S069 Sep 2, 2026 90d
Abbott
 CentriMag™ Circulatory Support System Cardiovascular PMA Supplement Approved (30-day notice) P170038/S032 Sep 2, 2026 29d
Abbott Molecular, Inc.
 Alinity m HR HPV Diagnostics PMA Supplement Approved (30-day notice) P230003/S019 Sep 2, 2026 5d
Sequitur Health Corp.
 AMI™ Plasma Cartridge, AMI™ Diagnostics 510(k) Cleared K260613 Sep 1, 2026 188d
Karl Storz SE & CO. KG
 UNIDRIVE Select System Other 510(k) Cleared K260884 Sep 1, 2026 168d
Just Medical Devices (Tianjin) Co., Ltd.
 SK Knee System Orthopedic 510(k) Cleared K253961 Sep 1, 2026 265d
Eizo Corporation
 RadiForce MX247W Imaging 510(k) Cleared K262783 Sep 1, 2026 26d
GE Healthcare Finland Oy
 Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM … Cardiovascular 510(k) Cleared K260656 Sep 1, 2026 186d
Siemens Shenzhen Magnetic Resonance , Ltd.
 MAGNETOM Free.Max; MAGNETOM Free.Star Imaging 510(k) Cleared K260758 Sep 1, 2026 176d
PRIMED Medical Products, Inc.
 PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple … Surgical 510(k) Cleared K261811 Sep 1, 2026 92d
Beijing Mega Beauty Technology Co., Ltd.
 CO2 Laser System (MBT- CO2 Laser) Surgical 510(k) Cleared K262269 Sep 1, 2026 57d
Guangdong Horigen Mother & Baby Products Co., Ltd.
 Wearable breast pump (Model: XN/MD-2249BS, ZFHF) Women's Health 510(k) Cleared K262774 Sep 1, 2026 28d
Arthrex, Inc.
 Arthrex DynaNite Staples Orthopedic 510(k) Cleared K262451 Sep 1, 2026 46d
Berlin Heart, Inc.
 EXCOR Pediatric Ventricular Assist Device Cardiovascular PMA Supplement Approved P160035/S058 Sep 1, 2026 90d
Biomet Manufacturing Corp
 Oxford Partial Knee Anatomic Vivacit-E Meniscal Bearings Orthopedic PMA Supplement Approved (30-day notice) P010014/S118 Sep 1, 2026 28d
Abbott Diabetes Care, Inc.
 Freestyle Libre Flash Glucose Monitoring System Diagnostics PMA Supplement Approved (30-day notice) P160030/S058 Sep 1, 2026 26d
Abbott Diabetes Care, Inc.
 Freestyle Libre Pro Flash Glucose Monitoring System Diagnostics PMA Supplement Approved (30-day notice) P150021/S061 Sep 1, 2026 26d
Guilin Kevin Peter Technology Co., Ltd.
 Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) Dental 510(k) Cleared K261695 Aug 31, 2026 101d
Kam Yuen Plastic Products , Ltd.
 Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902 … Surgical 510(k) Cleared K260767 Aug 31, 2026 175d
Aura Wellness, LLC
 Nova HD+ Physical Medicine 510(k) Cleared K262788 Aug 31, 2026 25d
Abbott Diagnostics Scarborough, Inc.
 ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 Diagnostics 510(k) Cleared K262747 Aug 31, 2026 28d
Radformation, Inc.
 EZFluence (RADEZ V2) Imaging 510(k) Cleared K261718 Aug 31, 2026 97d
Hironic Co., Ltd.
 SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) Neurology 510(k) Cleared K260387 Aug 31, 2026 206d
Global Life Sciences Solutions USA, LLC
 Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter General Hospital 510(k) Cleared K261403 Aug 31, 2026 124d
Siemens Medical Solutions USA, Inc.
 MULTIX Impact; MULTIX Impact C Imaging 510(k) Cleared K260488 Aug 31, 2026 199d
Evolym, LLC
 Aerloom Cardiovascular 510(k) Cleared K254217 Aug 31, 2026 245d
Honsun (Nantong) Co., Ltd.
 Automatic Digital Blood Pressure monitor (LD-526) Cardiovascular 510(k) Cleared K262658 Aug 31, 2026 32d
Merz North America, Inc.
 Belotero® Intense (+) Lidocaine Surgical PMA Supplement Approved P250016/S004 Aug 31, 2026 27d
Pramand, LLC
 SpineSeal Spine Sealant Neurology PMA Supplement Approved P240027/S006 Aug 31, 2026 88d
Teoxane S.A.
 Rha 2, Rha 3, Rha 4 Surgical PMA Supplement Approved (30-day notice) P170002/S059 Aug 31, 2026 26d
Womed Sas
 Womed Leaf Women's Health PMA Supplement Approved P240015/S002 Aug 31, 2026 89d
Abbott Medical
 Tendyne Transcatheter Mitral Valve System Cardiovascular PMA Supplement Approved (30-day notice) P240042/S004 Aug 31, 2026 27d
AZmed
 Rayvolve AZchest Imaging 510(k) Cleared K261378 Aug 28, 2026 123d
Beijing Fule Science & Technology Development Co., Ltd.
 Fule Vertebroplasty Balloon Catheter Orthopedic 510(k) Cleared K260203 Aug 28, 2026 217d
Reflow Medical, Inc.
 Kiba CTO Crossing Catheter Cardiovascular 510(k) Cleared K262013 Aug 28, 2026 74d
GE Healthcare Finland Oy
 Carescape Canvas 1000; Carescape Canvas Smart Display Cardiovascular 510(k) Cleared K260343 Aug 28, 2026 207d
Ortler Global Tibbi Gerecler Anonim Sirketi
 FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog) … Orthopedic 510(k) Cleared K261830 Aug 28, 2026 87d
Medtronic, Inc.
 LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) Cardiovascular 510(k) Cleared K262735 Aug 28, 2026 28d
Medacta International S.A.
 Mpact 3D Metal Foam Orthopedic 510(k) Cleared K253630 Aug 28, 2026 282d
Roche Molecular Systems, Inc.
 cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190) … Diagnostics 510(k) Cleared K260047 Aug 28, 2026 233d
Imperative Care, Inc.
 Zoom 4S Catheter Cardiovascular 510(k) Cleared K261176 Aug 28, 2026 140d
Paragon 28, Inc.
 Primal K-Wire (P99-193-1410) Orthopedic 510(k) Cleared K262722 Aug 28, 2026 28d
Roche Molecular Systems, Inc.
 cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190) … Diagnostics 510(k) Cleared K260045 Aug 28, 2026 233d
X-Nav Technologies, LLC
 X-Guide Surgical Navigation System Dental 510(k) Cleared K253954 Aug 28, 2026 261d
Rapid Medical Ltd.
 Tigertriever 13 Ultra Revascularization Device Cardiovascular 510(k) Cleared K260617 Aug 28, 2026 184d
Zhejiang Curaway Medical Technology Co., Ltd.
 Automatic Core Biopsy Instrument Other 510(k) Cleared K260517 Aug 28, 2026 192d
Zhengzhou PZ Laser Slim Technology Co., Ltd.
 Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) Surgical 510(k) Cleared K261582 Aug 28, 2026 107d
Cell Store (Beijing) Biotechnology Co., LTD.
 Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK) Women's Health 510(k) Cleared K254261 Aug 28, 2026 241d
Boston Scientific Corporation
 AGENT Paclitaxel-Coated Balloon Catheter Cardiovascular PMA Supplement Approved (30-day notice) P230035/S010 Aug 28, 2026 28d
Boston Scientific Corp
 WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System … Cardiovascular PMA Supplement Approved (30-day notice) P130013/S090 Aug 28, 2026 30d
Teoxane S.A.
 Rha 2, Rha 3, Rha 4 Surgical PMA Supplement Approved (30-day notice) P170002/S058 Aug 28, 2026 25d
Abbott Medical
 Amplatzer™ Amulet™ Left Atrial Appendage Occluder Cardiovascular PMA Supplement Approved P200049/S021 Aug 28, 2026 18d
Anika Therapeutics, Inc.
 Orthovisc Injectable Intra-Articular Devices Orthopedic PMA Supplement Approved (30-day notice) P030019/S028 Aug 28, 2026 57d
Anika Therapeutics, Inc.
 Ophthalmic Viscosurgical Device Family Ophthalmic PMA Supplement Approved (30-day notice) P000046/S032 Aug 28, 2026 57d
Inspire Medical Systems
 Model 4063 Inspire Stimulation Lead Anesthesiology PMA Supplement Approved P130008/S136 Aug 28, 2026 196d
Physio-Control, Inc.
 Physio-Control LIFEPAK®35 monitor/defibrillator Cardiovascular PMA Supplement Approved (30-day notice) P160026/S072 Aug 28, 2026 17d
Allergan
 Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC and SKINVIVE by Juvéderm Surgical PMA Supplement Approved (30-day notice) P110033/S102 Aug 28, 2026 29d
Allergan
 Juvéderm Ultra XC, and Juvéderm Ultra Plus XC Surgical PMA Supplement Approved (30-day notice) P050047/S107 Aug 28, 2026 29d
Abbott Vascular
 XIENCE PROS Everolimus Eluting Coronary Stent System (XIENCE PRO5) … Cardiovascular PMA Supplement Approved (30-day notice) P110019/S144 Aug 28, 2026 28d
Stryker Neurovascular
 Surpass Elite™ Flow Diverter Neurology PMA Supplement Approved P170024/S027 Aug 28, 2026 39d
Inspire Medical Systems
 Inspire Ii Upper Airway Stimulator Anesthesiology PMA Supplement Approved P130008/S123 Aug 28, 2026 490d
Resmed Corp
 EasyCare Tx 2 Anesthesiology 510(k) Cleared K261360 Aug 27, 2026 125d
Olympus Medical Systems Corporation
 Evis Eus Ultrasound Bronchofibervideoscope Olympus Bf-Ucp190F (Bf-Ucp190F) Imaging 510(k) Cleared K260401 Aug 27, 2026 202d
Olympus Medical Systems Corporation
 Disposable Distal Attachment D-201-13404 Other 510(k) Cleared K260856 Aug 27, 2026 164d
Ascensia Diabetes Care
 CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System … Diagnostics 510(k) Cleared K260545 Aug 27, 2026 190d
Stereotaxis, Inc.
 GenesisX RMN Cardiovascular 510(k) Cleared K262744 Aug 27, 2026 24d
Zhengzhou PZ Laser Slim Technology Co., Ltd.
 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) Surgical 510(k) Cleared K261821 Aug 27, 2026 87d
Zhejiang Qiangnao Technology Co.,Ltd
 Dexus Prosthetic System (MSL2, MSR2) Neurology 510(k) Cleared K262654 Aug 27, 2026 28d
Gebauer Company
 Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) Other 510(k) Cleared K260870 Aug 27, 2026 163d
VIOL Co., Ltd.
 Scarlet Pro (Scarlet Pro) Surgical 510(k) Cleared K253859 Aug 27, 2026 267d
Samsung Electronics Co., Ltd.
 Gc85A Imaging 510(k) Cleared K260481 Aug 27, 2026 195d
Olympus Medical Systems Corporation
 Gastrointestinal Videoscope Olympus GIF-2T1500 Other 510(k) Cleared K260824 Aug 27, 2026 167d
Berkeley Advanced Biomaterials
 Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP) … Other 510(k) Cleared K260711 Aug 27, 2026 175d
Prismatik Dentalcraft, Inc.
 Glidewell™ Denture Base Resin Dental 510(k) Cleared K261802 Aug 27, 2026 87d
Fisher and Paykel Healthcare Limited
 Optiflow Oxygen Kit (AA484J) Anesthesiology 510(k) Cleared K262268 Aug 27, 2026 52d
Ram.Shaw Pte., Ltd.
 Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) Dental 510(k) Cleared K262104 Aug 27, 2026 65d
Piraeus Medical, Inc.
 35 Helix Guidewire Cardiovascular 510(k) Cleared K260751 Aug 27, 2026 174d
Riverpoint Medical
 Iconix Knotless T Orthopedic 510(k) Cleared K262677 Aug 27, 2026 28d
Geneoscopy, Inc.
 ColoSense® Diagnostics PMA Supplement Approved P230001/S012 Aug 27, 2026 209d
ZOLL Medical Corporation
 ResQCPR System Cardiovascular PMA Supplement Approved (30-day notice) P110024/S007 Aug 27, 2026 28d
ETHICON, Inc.
 ETHIZIA™ Hemostatic Patch Surgical PMA Supplement Approved P240035/S004 Aug 27, 2026 209d
Renata Medical, Inc.
 Minima Stent System; Minima Pro Stent System Cardiovascular PMA Supplement Approved P240003/S008 Aug 27, 2026 42d
Abbott Vascular, Inc.
 Perclose ProGlide Suture-Mediated Closure System and Perclose ProStyle Suture-Mediated Closure and Repair … Cardiovascular PMA Supplement Approved P960043/S128 Aug 27, 2026 268d
DiaSorin, Inc.
 LIAISON QuantiFERON-TB Gold III; LIAISON Control QuantiFERON-TB Gold III; LIAISON QuantiFERON-TB Gold Plus II … Diagnostics PMA Supplement Approved P180047/S045 Aug 27, 2026 90d
DiaSorin, Inc.
 LIAISON QuantiFERON-TB Gold Plus; LIAISON XL Control QuantiFERON-TB Gold Plus … Diagnostics PMA Supplement Approved P180047/S043 Aug 27, 2026 176d
Spineart USA, Inc.
 BAGUERA®C Cervical Disc Prosthesis Orthopedic PMA Supplement Approved (30-day notice) P250042/S001 Aug 27, 2026 14d
Abbott Medical
 Aveir VR Leadless System Cardiovascular PMA Supplement Approved P150035/S041 Aug 27, 2026 90d
Depuy, Inc.
 LCS® Total Knee System Orthopedic PMA Supplement Approved (30-day notice) P830055/S373 Aug 27, 2026 7d
DePuy Orthopaedics, Inc.
 CERAMAX Ceramic Hip System Orthopedic PMA Supplement Approved (30-day notice) P070026/S130 Aug 27, 2026 7d
Biotronik, Inc.
 Solia CSP S Cardiovascular PMA Supplement Approved (30-day notice) P950037/S297 Aug 27, 2026 27d
Oticon Medical AB
 Ponto 5 Mini; Ponto 5 Superpower Other 510(k) Cleared K261142 Aug 26, 2026 141d
Manteia Technologies Co., Ltd.
 MRIA Radiation Therapy Information System (MRIA) Imaging 510(k) Cleared K260733 Aug 26, 2026 173d
JOYTECH Healthcare Co., Ltd.
 Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus … Cardiovascular 510(k) Cleared K261394 Aug 26, 2026 119d
Maquet Critical Care AB
 Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273) … Other 510(k) Cleared K253715 Aug 26, 2026 275d
SurGenTec, LLC
 GraftGun Universal Graft Delivery System (GDS®) General Hospital 510(k) Cleared K262581 Aug 26, 2026 30d
Karl Storz SE & CO. KG
 HOPKINS Telescopes for Arthroscopy Orthopedic 510(k) Cleared K254103 Aug 26, 2026 250d
Sony Corporation
 OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor Other 510(k) Cleared K260972 Aug 26, 2026 155d
Bioventus, LLC
 StimTrial Neuromodulation System Neurology 510(k) Cleared K253877 Aug 26, 2026 265d
Heartvue.ai, Inc.
 Heartvue.Proton Imaging 510(k) Cleared K260811 Aug 26, 2026 167d
Wenzel Spine, Inc.
 VariLift-C Cervical Interbody Fusion System Orthopedic 510(k) Cleared K262595 Aug 26, 2026 30d
Principle & Will Co., Ltd.
 Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & … Surgical 510(k) Cleared K260407 Aug 26, 2026 198d
Boston Scientific Corporation
 LithoVue Elite Digital Flexible Ureteroscope System Other 510(k) Cleared K261153 Aug 26, 2026 140d
Medtronic Sofamor Danek USA, Inc.
 Infuse Bone Graft/Lt-Cage Lumbar Tapered Fusion Device Orthopedic PMA Supplement Approved P000058/S095 Aug 26, 2026 530d
Medtronic, Inc.
 Infuse Bone Graft Dental PMA Supplement Approved P050053/S066 Aug 26, 2026 530d
Siemens Healthcare Diagnostics, Inc.
 Atellica IM Total PSA II (tPSAII) Diagnostics PMA Supplement Approved P240021/S001 Aug 26, 2026 180d
Seikagaku Corp.
 Supartz Fx Orthopedic PMA Supplement Approved (30-day notice) P980044/S068 Aug 26, 2026 27d
Medtronic Sofamor Danek USA, Inc.
 Infuse Bone Graft Orthopedic PMA Supplement Approved P000054/S075 Aug 26, 2026 530d
Freenome, LLC
 SimpleScreen™ CRC Other PMA Supplement Approved (30-day notice) P250029/S001 Aug 26, 2026 30d
Hologic, Inc.
 Rapid fFN for the TLiIQ System Other PMA Supplement Approved (30-day notice) P920048/S030 Aug 26, 2026 29d
Seikagaku Corp.
 Gel-One Orthopedic PMA Supplement Approved (30-day notice) P080020/S057 Aug 26, 2026 26d
Philips Image Guided Therapy Corporation
 Duo Venous Stent System Cardiovascular PMA Supplement Approved (30-day notice) P230021/S004 Aug 26, 2026 30d
Guilin Kevin Peter Technology Co., Ltd.
 Calcium Hydroxide Temporary Filling Material (KP-Cal) Dental 510(k) Cleared K261514 Aug 25, 2026 110d
Promisemed Hangzhou Meditech Co., Ltd.
 Promisemed X-Safety Pen Needle General Hospital 510(k) Cleared K261719 Aug 25, 2026 91d
Sol-Millennium Medical, Inc.
 SOL-M Luer Lock Syringe with Exchangeable Needle Tray General Hospital 510(k) Cleared K252184 Aug 25, 2026 410d
Beacon Biosignals, Inc.
 Report Studio Neurology 510(k) Cleared K261747 Aug 25, 2026 90d
Abbott Diabetes Care
 Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System Diagnostics De Novo Granted DEN250049 Aug 25, 2026 330d
Taiwan Surgical Corporation
 Inno-Switch™ Laparoscopic Instruments Surgical 510(k) Cleared K252535 Aug 25, 2026 378d
Samyang Holdings Corporation
 Monofix Pdo Surgical 510(k) Cleared K253879 Aug 25, 2026 264d
SteriLance Medical (Suzhou), Inc.
 Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense) Surgical 510(k) Cleared K262631 Aug 25, 2026 27d
Ceevra, Inc.
 Ceevra Reveal 4 Imaging 510(k) Cleared K261595 Aug 25, 2026 103d
Achaemenid, LLC
 iNOS intraoral biosensor Dental 510(k) Cleared K254304 Aug 25, 2026 237d
Ventana Medical Systems, Inc.
 PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody Diagnostics PMA Supplement Approved P990081/S060 Aug 25, 2026 153d
Boston Scientific Corp
 Tachy Pulse Generators Cardiovascular PMA Supplement Approved P010012/S612 Aug 25, 2026 83d
Ventana Medical Systems, Inc.
 VENTANA HER2 Dual ISH DNA Probe Cocktail Diagnostics PMA Supplement Approved P190031/S016 Aug 25, 2026 153d
Farapulse, Inc.
 FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter … Cardiovascular PMA Supplement Approved P230030/S016 Aug 25, 2026 389d
Defibtech, LLC
 Lifeline VIEW 2, Lifeline VIEW 2 AUTO and Lifeline ECG 2 AED Cardiovascular PMA Supplement Approved P160032/S017 Aug 25, 2026 8d
Boston Scientific
 Tachy Pulse Generators Cardiovascular PMA Supplement Approved P960040/S515 Aug 25, 2026 83d
Biomet Orthopedics, Inc.
 Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments Orthopedic 510(k) Cleared K253515 Aug 24, 2026 290d
Abmrc, LLC
 BiWaze Clear System Anesthesiology 510(k) Cleared K260604 Aug 24, 2026 181d
DentalMaster(Xiamen)Medical Technology Co., Ltd.
 Guided Bone Regeneration System Dental 510(k) Cleared K254286 Aug 24, 2026 236d
SurGenTec, LLC
 TiLink-L™ SI Joint Fusion System Orthopedic 510(k) Cleared K261381 Aug 24, 2026 119d
Sonoscape Medical Corp.
 Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 … Imaging 510(k) Cleared K254027 Aug 24, 2026 251d
Flower Orthopedics Corporation DBA Conventus Flower Orthoped
 OsteoCoil™ GT Active Compression System Orthopedic 510(k) Cleared K260106 Aug 24, 2026 222d
Bolt Medical, Inc.
 SEISMIQ™ Intravascular Lithotripsy System Cardiovascular 510(k) Cleared K260246 Aug 24, 2026 209d
BTL Industries, Inc.
 Btl-699 Neurology 510(k) Cleared K260691 Aug 23, 2026 173d
GM Dos Reis Industria e Comercio Ltda.
 Stitch - Suture Wires and Tapes Surgical 510(k) Cleared K253910 Aug 22, 2026 257d
Medtronic, Inc.
 Affera Integrated Mapping System Cardiovascular 510(k) Cleared K262005 Aug 21, 2026 67d
Brixton Biosciences
 ReneuRx™ (Neural Ice) Orthopedic De Novo Granted DEN250067 Aug 21, 2026 249d
Mediclus Co., Ltd.
 Any-Zircos Dental 510(k) Cleared K262074 Aug 21, 2026 60d
Gi View, Ltd.
 Solo Scope Colonoscope System Other 510(k) Cleared K261015 Aug 21, 2026 147d
Zeus Scientific
 Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM Diagnostics 510(k) Cleared K261466 Aug 21, 2026 109d
Matap Ii, LLC
 Avulux Neurology De Novo Granted DEN250026 Aug 21, 2026 424d
Cimilre Co., Ltd.
 Cimilre Dual Max Women's Health 510(k) Cleared K260643 Aug 21, 2026 175d
Osseus Fusions Systems, LLC
 Pisces-SC Standalone Cervical Interbody System Orthopedic 510(k) Cleared K261882 Aug 21, 2026 77d
Tempus AI, Inc.
 Tempus ECG-PH Cardiovascular 510(k) Cleared K253699 Aug 21, 2026 270d
Microport Orthopedics, Inc.
 EVOLUTION® AM BIOFOAM® Tibial System Orthopedic 510(k) Cleared K253728 Aug 21, 2026 270d
Boston Scientific
 AVVIGO™+ Multi-Modality Guidance System Cardiovascular 510(k) Cleared K253692 Aug 21, 2026 273d
Foshan Sowell Medical Technology Co., Ltd.
 Electric wheelchair (D03) Physical Medicine 510(k) Cleared K261354 Aug 21, 2026 119d
Shanghai United Imaging Healthcare Co., Ltd.
 uAngio AVIVA CX Imaging 510(k) Cleared K253726 Aug 21, 2026 270d
Apyx Medical Corporation
 AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula Adaptors Surgical 510(k) Cleared K261710 Aug 21, 2026 91d
Hangzhou Tappa Medical Technology Co., Ltd.
 Disposable Warming Blanket Cardiovascular 510(k) Cleared K262089 Aug 21, 2026 60d
Mriguidance B.V.
 BoneMRI Imaging 510(k) Cleared K260584 Aug 21, 2026 182d
Inari Medical, Inc.
 Artix™ MT;Artix™ Thin-Walled Sheath Cardiovascular 510(k) Cleared K262538 Aug 21, 2026 29d
Immunodiagnostics Systems Limited
 IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La Diagnostics 510(k) Cleared K253817 Aug 21, 2026 266d
Dentsply Sirona
 DS Core CBCT Anatomy Imaging 510(k) Cleared K262127 Aug 21, 2026 58d
Medtronic, Inc.
 Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (B31050, B31040, B31010, B31000, B32000 … Neurology PMA Supplement Approved (30-day notice) P960009/S539 Aug 21, 2026 60d
Boston Scientific Corporation
 Innova™ Vascular Self-Expanding Stent with Delivery System Cardiovascular PMA Supplement Approved (30-day notice) P140028/S088 Aug 21, 2026 28d
Medtronic, Inc.
 INS PERCEPT RC Vl Deep Brain Stimulation (DBS) Implantable Neurostimulators … Neurology PMA Supplement Approved (30-day notice) P960009/S543 Aug 21, 2026 29d
Depuy, Inc.
 LCS® Total Knee System- ATTUNE™ Revision Rotating Platform Knee System Orthopedic PMA Supplement Approved (30-day notice) P830055/S369 Aug 21, 2026 30d
Neuspera Medical, Inc.
 Neuspera Sacral Neuromodulation (SNM) System Other PMA Supplement Approved P240031/S005 Aug 21, 2026 81d
Medtronic Neuromodulation
 Inceptiv Implantable Neurostimulator, Vanta™ with AdaptiveStim™ Implantable Neurostimulator … Neurology PMA Supplement Approved (30-day notice) P840001/S633 Aug 21, 2026 29d
Boston Scientific Corp
 Epic™ Vascular Self-Expanding Stent System Cardiovascular PMA Supplement Approved (30-day notice) P110035/S079 Aug 21, 2026 28d
Spectranetics Corp.
 Philips Laser System Cardiovascular PMA Supplement Approved (30-day notice) P910001/S127 Aug 21, 2026 29d
Boston Scientific Corporation
 SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGY XD Everolimus-Eluting Platinum … Cardiovascular PMA Supplement Approved (30-day notice) P150003/S113 Aug 21, 2026 28d
Depuy, Inc.
 LCS® Total Knee System Orthopedic PMA Supplement Approved (30-day notice) P830055/S371 Aug 21, 2026 8d
Boston Scientific Corp
 ELUVIA™ Drug-Eluting Vascular Stent System Cardiovascular PMA Supplement Approved (30-day notice) P180011/S070 Aug 21, 2026 28d
Medtronic, Inc.
 SynchroMed™ III Pump Drug Delivery Infusion Pump General Hospital PMA Supplement Approved (30-day notice) P860004/S461 Aug 21, 2026 29d
Boston Scientific Corp
 WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System WATCHMAN FLX™ Pro Left Atrial … Cardiovascular PMA Supplement Approved (30-day notice) P130013/S089 Aug 21, 2026 28d
Boston Scientific Corporation
 TheraSphere Imaging PMA Supplement Approved P200029/S014 Aug 21, 2026 30d
Hardy Diagnostics
 HardyDisk AST Tebipenem 10µg (TBP10) Diagnostics 510(k) Cleared K262113 Aug 20, 2026 58d
Convergence Medical Sciences , Ltd.
 Valence InVent Xtend™ (CVG-4101-VXA) Anesthesiology 510(k) Cleared K253807 Aug 20, 2026 265d
Virtual Incision
 MIRA Surgical System Surgical 510(k) Cleared K260817 Aug 20, 2026 160d
Kneu Health Digital , Ltd.
 Kneu Platform (V2) Neurology 510(k) Cleared K262515 Aug 20, 2026 30d
Remex Medical Corp.
 Remex Spine Surgery Navigation - Universal Instruments Neurology 510(k) Cleared K262506 Aug 20, 2026 30d
Cm Technologies, Inc.
 Qoramatic Automated Stool Management Other De Novo Granted DEN250043 Aug 20, 2026 339d
Medibyt , Ltd.
 CPETWise Platform Anesthesiology 510(k) Cleared K260242 Aug 20, 2026 206d
Guangdong Youmeng Electrical Technology Co., Ltd.
 Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) Women's Health 510(k) Cleared K261298 Aug 20, 2026 122d
Draeger Medical Systems, Inc.
 Infinity® Acute Care System (IACS) – VG8.1 Cardiovascular 510(k) Cleared K260579 Aug 20, 2026 181d
Spineart SA
 Scala® Tl Orthopedic 510(k) Cleared K261049 Aug 20, 2026 142d
Siemens Healthcare Diagnostics, Inc.
 IMMULITE Systems AFP Diagnostics PMA Supplement Approved (30-day notice) P010007/S027 Aug 20, 2026 28d
Siemens Healthcare Diagnostics, Inc.
 IMMULITE Systems PSA Diagnostics PMA Supplement Approved (30-day notice) P930027/S040 Aug 20, 2026 28d
Kardium, Inc.
 Globe® Catheter Laminated Ribs Cardiovascular PMA Supplement Approved (30-day notice) P240044/S006 Aug 20, 2026 27d
Abbott Medical
 HeartMate 3 Left Ventricular Assist System Cardiovascular PMA Supplement Approved (30-day notice) P160054/S133 Aug 20, 2026 27d
Siemens Medical Solutions Diagnostics Limited
 IMMULITE Systems Free PSA Diagnostics PMA Supplement Approved (30-day notice) P060005/S026 Aug 20, 2026 28d
Gyrus Acmi, Inc.
 Spiration® Valve System Anesthesiology PMA Supplement Approved P180007/S016 Aug 20, 2026 16d
Implantica CE Reflux , Ltd.
 RefluxStop® Device and RefluxStop® Deployment Tool Other PMA Approved P250018 Aug 20, 2026 423d
Hyperfine, Inc.
 Swoop® Portable MR Imaging® System Imaging 510(k) Cleared K262622 Aug 19, 2026 22d
CooperSurgical, Inc.
 Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK) Women's Health 510(k) Cleared K261083 Aug 19, 2026 140d
Nipro Technical Solutions, Incoporated
 Nipro Dry Acid Concentrate Mixer Other 510(k) Cleared K260799 Aug 19, 2026 161d
Pascall Systems, Inc.
 Pascall Sensor Unit (PSU1) Neurology 510(k) Cleared K254213 Aug 19, 2026 233d
Zeros Co., Ltd.
 ZEROS Dental Implant System Dental 510(k) Cleared K260463 Aug 19, 2026 188d
Vitestro
 Aletta® Autonomous Robotic Phlebotomy Device (ARPD™) (Gen1 US) General Hospital De Novo Granted DEN250046 Aug 19, 2026 327d
Hebei Zollvan Medical Technology Co., Ltd.
 Diode Laser Therapy Systems (DL612A) Surgical 510(k) Cleared K262070 Aug 19, 2026 58d
Roche Diagnostics
 Elecsys Phospho-Tau (217P) Plasma Diagnostics 510(k) Cleared K261686 Aug 19, 2026 90d
Elesta S.P.A
 Echolaser X4 Surgical 510(k) Cleared K261964 Aug 19, 2026 69d
GM Dos Reis Industria e Comercio Ltda.
 Versalock Sterile Plating System Orthopedic 510(k) Cleared K262537 Aug 19, 2026 27d
DRTECH Corporation
 Extron 3;Extron 6 Imaging 510(k) Cleared K261413 Aug 19, 2026 111d
Shokz Health Global Limited
 Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410 … Other 510(k) Cleared K253431 Aug 19, 2026 322d
C2N Diagnostics, LLC
 PrecivityAD2 Test Diagnostics 510(k) Cleared K253240 Aug 19, 2026 324d
Karl Storz SE & CO. KG
 ENDOFLATOR+; Smart Smoke Evacuation Women's Health 510(k) Cleared K260209 Aug 19, 2026 208d
Depuy, Inc.
 Lcs(R) Total Knee System Orthopedic PMA Supplement Approved (30-day notice) P830055/S370 Aug 19, 2026 22d
Medtronic, Inc.
 Medtronic(R) Transvene Lead System Cardiovascular PMA Supplement Approved (30-day notice) P920015/S307 Aug 19, 2026 20d
Becton, Dickinson and Company
 BD Onclarity HPV Assay Reagent Pack (SKU 444075) and BD COR™ HPV Extraction Trough (SKU 444074) Diagnostics PMA Supplement Approved P160037/S027 Aug 19, 2026 180d
NeuroPace, Inc.
 NeuroPace® RNS® System Neurology PMA Supplement Approved (30-day notice) P100026/S104 Aug 19, 2026 26d
Theramicro
 TeKBrace Solo Soft Tissue Reinforcement Device Surgical 510(k) Cleared K262729 Aug 18, 2026 18d
Grace Medical, Inc.
 Tympendi™ (810) Other 510(k) Cleared K260266 Aug 18, 2026 202d
Huizhou Foryou Medical Devices Co., Ltd.
 LUOFUCON® Wound Matrix Other 510(k) Cleared K254256 Aug 18, 2026 232d
Axora Medical, Inc.
 HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK) Women's Health 510(k) Cleared K260984 Aug 18, 2026 146d
Kossan International Sdn Bhd
 NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA … General Hospital 510(k) Cleared K260794 Aug 18, 2026 160d
L&K BIOMED Co., Ltd.
 BluEX Cervical Expandable Cage System Orthopedic 510(k) Cleared K262489 Aug 18, 2026 29d
Sight Sciences, Inc.
 TearCare System Ophthalmic 510(k) Cleared K262479 Aug 18, 2026 29d
Wallaby Medical
 p17 XR Microcatheter Cardiovascular 510(k) Cleared K254071 Aug 18, 2026 243d
AI Planning Logic, Inc.
 Lower Limb AI (LLAI) Imaging 510(k) Cleared K261641 Aug 18, 2026 92d
Tianjin Huahong Technology Co., Ltd.
 Lancing device Surgical 510(k) Cleared K262135 Aug 18, 2026 54d
DiaSorin, Inc.
 LIAISON Biotrin Parvovirus B19 IgG Plus; LIAISON Biotrin Control Parvovirus B19 IgG Plus Diagnostics PMA Supplement Approved P220034/S010 Aug 18, 2026 167d
Nevro Corporation
 HFX Dynamis System Neurology PMA Supplement Approved P130022/S069 Aug 18, 2026 487d
Xingaoyi Medical Equipment Co.,Ltd
 MagicScan-1.5, GreenMR Serenity 1.5T Imaging 510(k) Cleared K254250 Aug 17, 2026 231d
ImpediMed Limited
 MySOZO Software version 6.1.0.1 (SW version 6.1.0.1) Cardiovascular 510(k) Cleared K260224 Aug 17, 2026 203d
S.M.A.I.O
 KBA3D (v2.4.0) Imaging 510(k) Cleared K261500 Aug 17, 2026 103d
KLS-Martin L.P.
 KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti) … Dental 510(k) Cleared K260137 Aug 17, 2026 213d
Alcon Laboratories, LLC
 Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre- Loaded Delivery System … Ophthalmic PMA Supplement Approved P190018/S051 Aug 17, 2026 88d
Carl Zeiss Meditec Production, LLC
 Ct Lucia 602, Ct Lucia 202, Ct Lucia 611P, Ct Lucia 621P Ophthalmic PMA Supplement Approved (30-day notice) P100016/S027 Aug 17, 2026 25d
Biosense Webster, Inc.
 TX eco Cable Cardiovascular PMA Supplement Approved (30-day notice) P210027/S017 Aug 17, 2026 26d
Inspire Medical Systems
 Inspire Upper Airway Stimulation (UAS) System Anesthesiology PMA Supplement Approved (30-day notice) P130008/S143 Aug 17, 2026 24d
FIND Surgical Sciences Inc. D/B/A FIND Neuro
 CN-Suite™ Neurology 510(k) Cleared K260563 Aug 16, 2026 178d
Arbor Endovascular, LLC
 Willow 12 Guidewire Cardiovascular 510(k) Cleared K262424 Aug 14, 2026 29d
Screenpoint Medical B.V.
 Transpara (2.1.0) Imaging 510(k) Cleared K260898 Aug 14, 2026 149d
Bard Peripheral Vascular, Inc.
 EnCor EnCompass™ Breast Biopsy and Tissue Removal System Other 510(k) Cleared K262571 Aug 14, 2026 21d
Medtronic Ireland
 NC Euphora Rapid Exchange Balloon Dilatation Catheter Cardiovascular 510(k) Cleared K261428 Aug 14, 2026 106d
Spineart SA
 BAGUERA® C Cervical Disc Surgical Instruments Orthopedic 510(k) Cleared K262639 Aug 14, 2026 16d
Advahealth Solutions, LLC
 AdvaView Imaging 510(k) Cleared K262449 Aug 14, 2026 29d
Cerenovus, Inc.
 Micrusframe (Mfr100202); Micrusframe (Mfr100253); Micrusframe (Mfr100305); Micrusframe (Mfr100356) … Neurology 510(k) Cleared K262419 Aug 14, 2026 30d
Scivita Medical Technology Co., Ltd.
 Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) Other 510(k) Cleared K262552 Aug 14, 2026 21d
Boehringer Laboratories, LLC
 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® Other 510(k) Cleared K261890 Aug 14, 2026 70d
Schiller AG
 medilogFD Cardiovascular 510(k) Cleared K253562 Aug 14, 2026 270d
IMDS Operation B.V.
 NHanceIT Cardiovascular 510(k) Cleared K260559 Aug 14, 2026 176d
Radformation, Inc.
 AutoContour (RADAC V6) Imaging 510(k) Cleared K262452 Aug 14, 2026 28d
Jiangsu Enjosim Medical Technology Co., Ltd.
 Disposable Pen Injector (KXYC-03C02, KXYC-03A03) General Hospital 510(k) Cleared K253747 Aug 14, 2026 262d
Brain Ultimate, Inc.
 QuickVision Ultimate rTMS Neurology 510(k) Cleared K261228 Aug 14, 2026 121d
Empatica S.r.l.
 Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini … Neurology 510(k) Cleared K260374 Aug 14, 2026 190d
BMC Medical Co., Ltd.
 Portable Oxygen Concentrator (PO1 5B, PO1 6B) Anesthesiology 510(k) Cleared K260171 Aug 14, 2026 205d
Infinium Medical, Inc.
 Vital Signs Monitor (CLEO2) Cardiovascular 510(k) Cleared K260438 Aug 14, 2026 184d
Beijing Kreate Medical Co., Ltd.
 Redermax® Antibacterial Wound Matrix Other 510(k) Cleared K261646 Aug 14, 2026 88d
Spectranetics Corp.
 ELCA Coronary Laser Atherectomy Catheters Cardiovascular PMA Supplement Approved P910001/S126 Aug 14, 2026 141d
Medtronic Vascular
 Resolute Onyx Zotarolimus-Eluting Coronary Stent System Cardiovascular PMA Supplement Approved (30-day notice) P160043/S095 Aug 14, 2026 28d
Medtronic Neuromodulation
 InterStim™ Therapy System, Verify™ Evaluation System Other PMA Supplement Approved (30-day notice) P080025/S350 Aug 14, 2026 30d
Becton, Dickinson and Company
 BD Onclarity™ HPV Assay Diagnostics PMA Supplement Approved P160037/S028 Aug 14, 2026 84d
Illumina, Inc.
 TruSight Oncology Comprehensive Diagnostics PMA Supplement Approved P230011/S006 Aug 14, 2026 269d
Medtronic Neuromodulation
 Master Restore™, Itrel™, Synergy™, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems and … Neurology PMA Supplement Approved (30-day notice) P840001/S631 Aug 14, 2026 30d
Medtronic, Inc.
 Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ Neurology PMA Supplement Approved (30-day notice) P960009/S541 Aug 14, 2026 30d
Medtronic Neuromodulation
 InterStim™ Therapy System, Verify™ Evaluation System Other PMA Supplement Approved (30-day notice) P970004/S456 Aug 14, 2026 30d
Medtronic Neuromodulation
 Altaviva™ Other PMA Supplement Approved (30-day notice) P240011/S015 Aug 14, 2026 30d
Covidien LP
 BIS™ Advance pEEG Module Neurology 510(k) Cleared K260907 Aug 13, 2026 147d
Levo Medical Corporation
 Levo Gen 2 Tinnitus Therapy System Other 510(k) Cleared K260413 Aug 13, 2026 185d
Menicon Co, Ltd.
 MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution Ophthalmic 510(k) Cleared K253795 Aug 13, 2026 258d
Guangzhou Heygears IMC., Inc.
 UltraPrint Flexible Denture UV Dental 510(k) Cleared K261626 Aug 13, 2026 90d
Mikron Makina San. ve Tic. Ltd. Sti.
 Mikron Trauma Bone Plate& Screw System Orthopedic 510(k) Cleared K260277 Aug 13, 2026 196d
Hill-Rom, Inc.
 Dashboard (P007000) Cardiovascular 510(k) Cleared K260211 Aug 13, 2026 202d
Freyja Healthcare, LLC
 VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103) Other 510(k) Cleared K261139 Aug 13, 2026 128d
Beijing Winkonlaser Technology Limited
 High Intensity Focused Electromagnetic Stimulation Device (FE60) Physical Medicine 510(k) Cleared K253790 Aug 13, 2026 258d
Wellvii, Inc.
 BP Go (BPP-855) Cardiovascular 510(k) Cleared K261061 Aug 13, 2026 135d
GE Medical Systems
 AIR Recon DL Imaging 510(k) Cleared K253808 Aug 13, 2026 258d
Joytech Healthcare Co. , Ltd.
 Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P … Cardiovascular 510(k) Cleared K253425 Aug 13, 2026 316d
Aw Technologies Aps
 TrachFlush Anesthesiology 510(k) Cleared K261499 Aug 13, 2026 99d
Mediclus Co., Ltd.
 Any-Cem Dental 510(k) Cleared K254201 Aug 13, 2026 227d
CERENOVUS, Inc.
 CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set Cardiovascular 510(k) Cleared K262398 Aug 13, 2026 30d
Medtronic, Inc.
 SynchroMed Infusion System, Ascenda Intrathecal Catheters General Hospital PMA Supplement Approved (30-day notice) P860004/S460 Aug 13, 2026 27d
Endotronix, Inc.
 Cordella Pulmonary Artery Sensor System (CorPASS) Cardiovascular PMA Supplement Approved (30-day notice) P230040/S032 Aug 13, 2026 17d
Source: U.S. FDA via openFDA. 1591 decisions dated Jun 28, 2026 – Oct 26, 2026. Every row links to its FDA record. Last refreshed 2026-10-26 08:00. FDA publishes decided submissions only; pending reviews are not public data.
Showing the 900 most recent of 1,591 records. The complete set is published at data/submissions.json.