{
 "meta": {
  "generated_at": "2026-08-24T08:00:28",
  "source": "openFDA (api.fda.gov) - FDA device/510k + device/pma endpoints",
  "window_days": 120,
  "window_start": "2026-04-26",
  "window_end": "2026-08-24",
  "note": "Decided submissions only. FDA does not publish pending reviews."
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   "company": "Micro-Tech (Nanjing) Co., Ltd.",
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   "device": "Visualized Access and Delivery Catheter; PB Digital Controller",
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   "device": "OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)",
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   "device": "POYA 3.5mm Medial Proximal Tibia System",
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   "company": "Pixee Medical S.A.S.",
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   "category": "Neurology",
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   "date_received": "2025-11-28",
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   "country": "FR",
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   "company": "Wellspect AB",
   "parent": "Wellspect AB",
   "device": "LoFric Elle Pro",
   "category": "Other",
   "specialty": "Gastroenterology, Urology",
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   "cleared": true,
   "decision_date": "2026-04-24",
   "date_received": "2026-03-26",
   "product_code": "EZD",
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   "country": "SE",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260999",
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   "pathway": "510(k)",
   "company": "Penumbra, Inc.",
   "parent": "Penumbra",
   "device": "INDIGO\u00ae Aspiration System \u0096 INDIGO Link",
   "category": "Cardiovascular",
   "specialty": "Cardiovascular",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-24",
   "date_received": "2026-02-24",
   "product_code": "QEW",
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   "id": "K261043",
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   "company": "Globus Medical, Inc.",
   "parent": "Globus Medical, Inc.",
   "device": "AUTOBAHN\u0099 Nailing System",
   "category": "Orthopedic",
   "specialty": "Orthopedic",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-24",
   "date_received": "2026-03-31",
   "product_code": "HSB",
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   "country": "US",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261043",
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  },
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   "id": "K250234",
   "pathway": "510(k)",
   "company": "Epic Medical Pte. , Ltd.",
   "parent": "Epic Medical Pte. , Ltd.",
   "device": "SMARTeZ\u0099 Elastomeric Infusion Pump (RS series)",
   "category": "General Hospital",
   "specialty": "General Hospital",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-24",
   "date_received": "2025-01-27",
   "product_code": "MEB",
   "device_class": "2",
   "state": "",
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  },
  {
   "id": "P010015/S585",
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   "device": "Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRTP (W1TR02); Serena Quadripolar C",
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   "id": "P110023/S067",
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   "device": "Everflex\u0099 Self-Expanding Peripheral Stent System, EverFlex\u0099 Self-Expanding Peripheral Stent with Entrust\u0099 Delivery Syste",
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  {
   "id": "K252306",
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   "specialty": "General Hospital",
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   "cleared": true,
   "decision_date": "2026-04-22",
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   "product_code": "QVB",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252306",
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  {
   "id": "K253163",
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   "company": "Ever Fortune.Ai, Co., Ltd.",
   "parent": "Ever Fortune.Ai, Co., Ltd.",
   "device": "Efai Ersuite Ct Appendicitis Assessment System (Appen-Ct-100)",
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   "cleared": true,
   "decision_date": "2026-04-22",
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   "product_code": "QAS",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253163",
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  {
   "id": "K260570",
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   "company": "Carlsmed, Inc.",
   "parent": "Carlsmed, Inc.",
   "device": "corra\u0099 cervical plating system",
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   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-22",
   "date_received": "2026-02-19",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260570",
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  {
   "id": "K260239",
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   "company": "Jiangxi AOV Maternity & Baby Products Co., Ltd.",
   "parent": "Jiangxi AOV Maternity & Baby Products Co., Ltd.",
   "device": "Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862)",
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   "specialty": "Obstetrics/Gynecology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-22",
   "date_received": "2026-01-26",
   "product_code": "HGX",
   "device_class": "2",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260239",
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  {
   "id": "K253256",
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   "company": "Otto Bock Healthcare Products GmbH",
   "parent": "Otto Bock Healthcare Products GmbH",
   "device": "myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)",
   "category": "Neurology",
   "specialty": "Neurology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-22",
   "date_received": "2025-09-29",
   "product_code": "GXY",
   "device_class": "2",
   "state": "",
   "country": "AT",
   "review_days": 205,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253256",
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  {
   "id": "K253230",
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   "parent": "Erbe Elektromedizin GmbH",
   "device": "ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe",
   "category": "Surgical",
   "specialty": "General, Plastic Surgery",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-22",
   "date_received": "2025-09-29",
   "product_code": "GEH",
   "device_class": "2",
   "state": "",
   "country": "DE",
   "review_days": 205,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253230",
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  {
   "id": "K253765",
   "pathway": "510(k)",
   "company": "Ddc Technologies, Inc.",
   "parent": "Ddc Technologies, Inc.",
   "device": "Vanish Pro",
   "category": "Surgical",
   "specialty": "General, Plastic Surgery",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-22",
   "date_received": "2025-11-25",
   "product_code": "GEX",
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   "device": "Led Facial Mask (Mj-66Db, Mk-99, Mk-99A, Mk-99M, Mj-66C)",
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   "specialty": "General, Plastic Surgery",
   "status": "Cleared",
   "cleared": true,
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   "product_code": "OHS",
   "device_class": "2",
   "state": "",
   "country": "FR",
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   "id": "K260237",
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   "company": "Wuyi Aichi Industry and Trade Co., Ltd.",
   "parent": "Wuyi Aichi Industry and Trade Co., Ltd.",
   "device": "Mobility Scooter (X-12, X-14, X-17)",
   "category": "Physical Medicine",
   "specialty": "Physical Medicine",
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   "cleared": true,
   "decision_date": "2026-04-22",
   "date_received": "2026-01-26",
   "product_code": "INI",
   "device_class": "2",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260237",
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   "parent": "Shanghai United Imaging Healthcare Co., Ltd.",
   "device": "uOmnispace.MR",
   "category": "Imaging",
   "specialty": "Radiology",
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   "cleared": true,
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   "date_received": "2025-09-23",
   "product_code": "QIH",
   "device_class": "2",
   "state": "",
   "country": "CN",
   "review_days": 211,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253077",
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   "specialty": "Cardiovascular",
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   "cleared": true,
   "decision_date": "2026-04-22",
   "date_received": "2026-03-23",
   "product_code": "LWS",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910073",
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   "id": "P130017/S069",
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   "company": "Exact Sciences Corporation",
   "parent": "Exact Sciences Corporation",
   "device": "Cologuard\u00ae",
   "category": "Diagnostics",
   "specialty": "Pathology",
   "status": "Approved (30-day notice)",
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   "decision_date": "2026-04-22",
   "date_received": "2026-03-27",
   "product_code": "PHP",
   "device_class": "3",
   "state": "WI",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130017",
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   "id": "P010012/S606",
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   "company": "Boston Scientific Corp",
   "parent": "Boston Scientific",
   "device": "ACUITY Spiral (Model 4592); ACUITY X4 Straight (Model 4593); ACUITY X4 Straight (Model 4672); ACUITY X4 Spiral S (Model",
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   "specialty": "Cardiovascular",
   "status": "Approved (30-day notice)",
   "cleared": true,
   "decision_date": "2026-04-22",
   "date_received": "2026-03-23",
   "product_code": "NIK",
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   "state": "MN",
   "country": "US",
   "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
   "review_days": 30,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010012",
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   "company": "Exact Sciences Corporation",
   "parent": "Exact Sciences Corporation",
   "device": "Cologuard Plus\u0099",
   "category": "Diagnostics",
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   "date_received": "2026-03-27",
   "product_code": "PHP",
   "device_class": "3",
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   "id": "P150033/S225",
   "pathway": "PMA Supplement",
   "company": "Medtronic, Inc.",
   "parent": "Medtronic",
   "device": "Micra Transcatheter Pacing System",
   "category": "Cardiovascular",
   "specialty": "Cardiovascular",
   "status": "Approved",
   "cleared": true,
   "decision_date": "2026-04-22",
   "date_received": "2026-03-20",
   "product_code": "PNJ",
   "device_class": "3",
   "state": "MN",
   "country": "US",
   "supplement_reason": "Postapproval Study Protocol",
   "review_days": 33,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150033",
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   "id": "P070004/S048",
   "pathway": "PMA Supplement",
   "company": "Tiger Aesthetics Medical, LLC",
   "parent": "Tiger Aesthetics Medical, LLC",
   "device": "Sientra Silicone Gel Breast Implants",
   "category": "Surgical",
   "specialty": "General, Plastic Surgery",
   "status": "Approved (30-day notice)",
   "cleared": true,
   "decision_date": "2026-04-22",
   "date_received": "2026-03-25",
   "product_code": "FTR",
   "device_class": "3",
   "state": "WI",
   "country": "US",
   "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
   "review_days": 28,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070004",
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   "id": "K260573",
   "pathway": "510(k)",
   "company": "EvoEndo, Inc.",
   "parent": "EvoEndo, Inc.",
   "device": "EvoEndo Single-Use Endoscopy System",
   "category": "Other",
   "specialty": "Gastroenterology, Urology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-21",
   "date_received": "2026-02-20",
   "product_code": "FDS",
   "device_class": "2",
   "state": "IL",
   "country": "US",
   "review_days": 60,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260573",
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   "parent": "Medtronic",
   "device": "CD Horizon\u0099 ModuLeX\u0099 Fenestrated Screw Set; CD Horizon\u0099 ModuLeX\u0099 Spinal System",
   "category": "Orthopedic",
   "specialty": "Orthopedic",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-21",
   "date_received": "2026-01-23",
   "product_code": "NKB",
   "device_class": "2",
   "state": "TN",
   "country": "US",
   "review_days": 88,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260216",
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   "archive_reason": "aged out of active window"
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  {
   "id": "K260518",
   "pathway": "510(k)",
   "company": "Shenzhen Semlamp Intelligent Technology Co., Ltd.",
   "parent": "Shenzhen Semlamp Intelligent Technology Co., Ltd.",
   "device": "IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)",
   "category": "Surgical",
   "specialty": "General, Plastic Surgery",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-21",
   "date_received": "2026-02-17",
   "product_code": "OHT",
   "device_class": "2",
   "state": "",
   "country": "CN",
   "review_days": 63,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260518",
   "first_seen": "2026-07-28",
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   "archived_on": "2026-08-24",
   "archive_reason": "aged out of active window"
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   "id": "K253982",
   "pathway": "510(k)",
   "company": "Beijing Hanvon Health Technology Co., Ltd.",
   "parent": "Beijing Hanvon Health Technology Co., Ltd.",
   "device": "Korotkoff sound blood pressure monitor",
   "category": "Cardiovascular",
   "specialty": "Cardiovascular",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-21",
   "date_received": "2025-12-12",
   "product_code": "DXN",
   "device_class": "2",
   "state": "",
   "country": "CN",
   "review_days": 130,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253982",
   "first_seen": "2026-07-28",
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   "id": "K250793",
   "pathway": "510(k)",
   "company": "RhythMedix, LLC",
   "parent": "RhythMedix, LLC",
   "device": "RhythmStar System (SL)",
   "category": "Cardiovascular",
   "specialty": "Cardiovascular",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-21",
   "date_received": "2025-03-14",
   "product_code": "QYX",
   "device_class": "2",
   "state": "NJ",
   "country": "US",
   "review_days": 403,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250793",
   "first_seen": "2026-07-28",
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   "id": "K260447",
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   "category": "General Hospital",
   "specialty": "General Hospital",
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   "device": "Celerity 5 HP Biological Indicator (LCB052)",
   "category": "General Hospital",
   "specialty": "General Hospital",
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   "date_received": "2026-03-09",
   "product_code": "FRC",
   "device_class": "2",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260766",
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   "device": "Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap",
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   "specialty": "Gastroenterology, Urology",
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   "cleared": true,
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   "specialty": "Unknown",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-08",
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   "id": "K252765",
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   "id": "K253862",
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   "product_code": "LNH",
   "device_class": "2",
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   "country": "JP",
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   "id": "K254091",
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   "company": "YAMAHACHI DENTAL MFG., Co.",
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   "specialty": "Gastroenterology, Urology",
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   "cleared": true,
   "decision_date": "2026-04-06",
   "date_received": "2025-09-03",
   "product_code": "QRC",
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   "device": "Light-curing Coloring Materials (ALCM)",
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   "specialty": "Dental",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-06",
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   "product_code": "EBF",
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   "id": "K250208",
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   "company": "Uzinmedicare Co., Ltd.",
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   "device": "SPECTRA Wearable 2",
   "category": "Women's Health",
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   "cleared": true,
   "decision_date": "2026-04-06",
   "date_received": "2025-01-24",
   "product_code": "HGX",
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   "country": "KR",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250208",
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   "id": "K252182",
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   "company": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.",
   "parent": "Shenzhen Mindray Bio-Medical Electronics Co., Ltd.",
   "device": "SV70 Ventilator (SV70)",
   "category": "Anesthesiology",
   "specialty": "Anesthesiology",
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   "cleared": true,
   "decision_date": "2026-04-06",
   "date_received": "2025-07-11",
   "product_code": "MNT",
   "device_class": "2",
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   "country": "CN",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252182",
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   "id": "K260720",
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   "company": "MED-EL Elektromedizinische Ger\u00e4te GmbH",
   "parent": "MED-EL Elektromedizinische Ger\u00e4te GmbH",
   "device": "mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735)",
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   "specialty": "Ear, Nose, Throat",
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   "cleared": true,
   "decision_date": "2026-04-03",
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   "product_code": "ETB",
   "device_class": "2",
   "state": "",
   "country": "AT",
   "review_days": 29,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260720",
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   "parent": "Cixi Ruihong Electric Appliance Co., Ltd.",
   "device": "Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)",
   "category": "Women's Health",
   "specialty": "Obstetrics/Gynecology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-03",
   "date_received": "2025-08-29",
   "product_code": "HGX",
   "device_class": "2",
   "state": "",
   "country": "CN",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252744",
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   "device": "uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)",
   "category": "Imaging",
   "specialty": "Radiology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-03",
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   "product_code": "KPS",
   "device_class": "2",
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   "country": "CN",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260524",
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   "id": "DEN240071",
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   "parent": "Automated Imaging Diagnostics, LLC",
   "device": "neuropacs",
   "category": "Neurology",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN240071",
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   "device": "HYALEX\u00ae MTP Hemiarthroplasty Implant",
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   "specialty": "Orthopedic",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-03",
   "date_received": "2025-01-10",
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   "device_class": "2",
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   "country": "US",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250074",
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   "parent": "Stryker",
   "device": "Blueprint Patient-Specific Instrumentation",
   "category": "Orthopedic",
   "specialty": "Orthopedic",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-03",
   "date_received": "2025-11-21",
   "product_code": "PHX",
   "device_class": "2",
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   "country": "FR",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253674",
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   "parent": "Tyber Medical, LLC",
   "device": "Tyber Medical Trauma Screw",
   "category": "Orthopedic",
   "specialty": "Orthopedic",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-03",
   "date_received": "2025-09-22",
   "product_code": "HWC",
   "device_class": "2",
   "state": "PA",
   "country": "US",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253042",
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   "id": "K260363",
   "pathway": "510(k)",
   "company": "Ceribell, Inc.",
   "parent": "Ceribell, Inc.",
   "device": "Ceribell Brain Monitor Headband",
   "category": "Neurology",
   "specialty": "Neurology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-03",
   "date_received": "2026-02-04",
   "product_code": "GXY",
   "device_class": "2",
   "state": "CA",
   "country": "US",
   "review_days": 58,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260363",
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   "pathway": "510(k)",
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   "parent": "Zhongshan A&J Medical Equipment Co., Ltd.",
   "device": "Electric Wheelchair (AL-208S-063)",
   "category": "Physical Medicine",
   "specialty": "Physical Medicine",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-04-03",
   "date_received": "2025-09-30",
   "product_code": "ITI",
   "device_class": "2",
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   "device": "VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 \u00b5g/mL)",
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   "decision_date": "2026-03-26",
   "date_received": "2026-01-29",
   "product_code": "LON",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260281",
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   "device": "Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)",
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   "state": "",
   "country": "CN",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260273",
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   "date_received": "2025-11-19",
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   "device_class": "2",
   "state": "",
   "country": "FI",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253627",
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   "id": "K253379",
   "pathway": "510(k)",
   "company": "Medtronic Navigation, Inc.",
   "parent": "Medtronic",
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   "category": "Neurology",
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   "decision_date": "2026-03-26",
   "date_received": "2025-09-30",
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   "parent": "Blue Belt Technologies, Inc.",
   "device": "Real Intelligence\u0099 Cori\u0099",
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   "date_received": "2026-02-24",
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   "review_days": 30,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260601",
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   "device": "DeVilbiss 5 Liter Oxygen Concentrator (555)",
   "category": "Anesthesiology",
   "specialty": "Anesthesiology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-03-26",
   "date_received": "2025-11-14",
   "product_code": "CAW",
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   "device": "Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)",
   "category": "Other",
   "specialty": "Gastroenterology, Urology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-03-26",
   "date_received": "2025-09-15",
   "product_code": "QSM",
   "device_class": "2",
   "state": "NV",
   "country": "US",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252926",
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   "id": "K253796",
   "pathway": "510(k)",
   "company": "Lunit, Inc.",
   "parent": "Lunit, Inc.",
   "device": "Lunit INSIGHT DBT (V1.2)",
   "category": "Imaging",
   "specialty": "Radiology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-03-26",
   "date_received": "2025-11-28",
   "product_code": "QDQ",
   "device_class": "2",
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   "country": "KR",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253796",
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   "company": "Airs Medical, Inc.",
   "parent": "Airs Medical, Inc.",
   "device": "SwiftMR",
   "category": "Imaging",
   "specialty": "Radiology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-03-26",
   "date_received": "2025-11-26",
   "product_code": "QIH",
   "device_class": "2",
   "state": "",
   "country": "KR",
   "review_days": 120,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253775",
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   "id": "P170008/S062",
   "pathway": "PMA Supplement",
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   "device": "NanoKnife Generator (H78720300351US0)",
   "category": "Surgical",
   "specialty": "General, Plastic Surgery",
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   "id": "P140029/S054",
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   "company": "Q-Med AB",
   "parent": "Q-Med AB",
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   "company": "Medtronic, Inc.",
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   "state": "MN",
   "country": "US",
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   "id": "P100016/S023",
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   "company": "Carl Zeiss Meditec Production, LLC",
   "parent": "Carl Zeiss Meditec Production, LLC",
   "device": "Ct Lucia 602; Ct Lucia 202; Ct Lucia 611P; Ct Lucia 621P",
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   "id": "K254112",
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   "company": "DiaDent Group International",
   "parent": "DiaDent Group International",
   "device": "Dia-X Sil Bite",
   "category": "Dental",
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   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-03-19",
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   "product_code": "ELW",
   "device_class": "2",
   "state": "",
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   "id": "K254269",
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   "company": "St. shine Optical Co., Ltd.",
   "parent": "St. shine Optical Co., Ltd.",
   "device": "Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens",
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   "specialty": "Ophthalmic",
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   "cleared": true,
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   "country": "TW",
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   "id": "K260509",
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   "company": "Radformation, Inc.",
   "parent": "Radformation, Inc.",
   "device": "AutoContour (RADAC V5)",
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   "cleared": true,
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   "state": "NY",
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   "id": "K253139",
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   "company": "Mirco-Tech (Nanjing) Co., Ltd.",
   "parent": "Mirco-Tech (Nanjing) Co., Ltd.",
   "device": "Disposable Distal Cap",
   "category": "Other",
   "specialty": "Gastroenterology, Urology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-03-19",
   "date_received": "2025-09-25",
   "product_code": "FBN",
   "device_class": "2",
   "state": "",
   "country": "CN",
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   "category": "Other",
   "specialty": "Unknown",
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   "date_received": "2026-02-17",
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   "device_class": "U",
   "state": "",
   "country": "CH",
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   "device": "Elisio\u0099-H",
   "category": "Other",
   "specialty": "Gastroenterology, Urology",
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   "cleared": true,
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   "date_received": "2026-02-17",
   "product_code": "KDI",
   "device_class": "2",
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   "country": "US",
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   "id": "K253965",
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   "company": "Wuhan PHOMED Technology Company , Ltd.",
   "parent": "Wuhan PHOMED Technology Company , Ltd.",
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   "parent": "Lake Region Medical",
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   "country": "IE",
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   "company": "L&K BIOMED Co., Ltd.",
   "parent": "L&K BIOMED Co., Ltd.",
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   "decision_date": "2026-03-19",
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   "country": "KR",
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   "id": "K253432",
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   "company": "Vy Spine, LLC",
   "parent": "Vy Spine, LLC",
   "device": "DiversiVy\u0099 Facet Screw System",
   "category": "Other",
   "specialty": "Unknown",
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   "country": "US",
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   "category": "Physical Medicine",
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   "date_received": "2025-07-03",
   "product_code": "ITI",
   "device_class": "2",
   "state": "",
   "country": "JP",
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   "parent": "Senseonics, Incorporated",
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   "specialty": "Clinical Chemistry",
   "status": "Approved",
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   "decision_date": "2026-03-19",
   "date_received": "2026-02-23",
   "product_code": "QCD",
   "device_class": "3",
   "state": "MD",
   "country": "US",
   "supplement_reason": "Postapproval Study Protocol",
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   "id": "P160049/S028",
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   "company": "The Spectranetics Corp.",
   "parent": "The Spectranetics Corp.",
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   "specialty": "Cardiovascular",
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   "decision_date": "2026-03-19",
   "date_received": "2026-02-26",
   "product_code": "ONU",
   "device_class": "3",
   "state": "CA",
   "country": "US",
   "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
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   "device": "\u0093FLNT Base\u0094 and \u0093FLNT Temp\u0094",
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   "company": "Mobia Medical, Inc.",
   "parent": "Mobia Medical, Inc.",
   "device": "Vivistim\u00ae System",
   "category": "Physical Medicine",
   "specialty": "Physical Medicine",
   "status": "Approved (30-day notice)",
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   "decision_date": "2026-03-02",
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   "device": "RelayPro Thoracic Stent-Graft System",
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   "parent": "Shenzhen TPH Technology Co., Ltd.",
   "device": "Wearable Breast Pump (Model W12)",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252420",
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   "id": "K252565",
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   "device": "PreOp v3",
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   "cleared": true,
   "decision_date": "2026-02-13",
   "date_received": "2025-08-14",
   "product_code": "OLX",
   "device_class": "2",
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   "device": "Wearable Breast Pump (Model W2)",
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   "specialty": "Obstetrics/Gynecology",
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   "country": "CN",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252422",
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  },
  {
   "id": "K252512",
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   "device": "Armada\u0099 14 NC PTA Catheter",
   "category": "Cardiovascular",
   "specialty": "Cardiovascular",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-02-13",
   "date_received": "2025-08-11",
   "product_code": "LIT",
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   "country": "US",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252512",
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   "company": "Contour Research, LLC",
   "parent": "Contour Research, LLC",
   "device": "Contour Light (CL-100)",
   "category": "Surgical",
   "specialty": "General, Plastic Surgery",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-02-13",
   "date_received": "2024-12-16",
   "product_code": "OLI",
   "device_class": "2",
   "state": "NV",
   "country": "US",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243854",
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  },
  {
   "id": "K254052",
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   "company": "Alcon Laboratories, Inc.",
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   "device": "DAILIES TOTAL1\u00ae; DAILIES TOTAL1\u00ae Multifocal",
   "category": "Ophthalmic",
   "specialty": "Ophthalmic",
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   "cleared": true,
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   "date_received": "2025-12-17",
   "product_code": "LPL",
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   "country": "US",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254052",
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  },
  {
   "id": "K251928",
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   "company": "Medinice S.A.",
   "parent": "Medinice S.A.",
   "device": "CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)",
   "category": "Surgical",
   "specialty": "General, Plastic Surgery",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-02-13",
   "date_received": "2025-06-23",
   "product_code": "GEH",
   "device_class": "2",
   "state": "",
   "country": "PL",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251928",
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  },
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   "id": "K253089",
   "pathway": "510(k)",
   "company": "Shenzhen Best Electronics Co., Ltd.",
   "parent": "Shenzhen Best Electronics Co., Ltd.",
   "device": "NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)",
   "category": "Cardiovascular",
   "specialty": "Cardiovascular",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-02-13",
   "date_received": "2025-09-23",
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   "state": "",
   "country": "CN",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253089",
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   "archive_reason": "seeded from FDA historical record"
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   "id": "K251619",
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   "company": "Dr\u00e4gerwerk AG & Co. KGaA",
   "parent": "Dr\u00e4gerwerk AG & Co. KGaA",
   "device": "Babyleo TN500",
   "category": "General Hospital",
   "specialty": "General Hospital",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-02-13",
   "date_received": "2025-05-27",
   "product_code": "FMZ",
   "device_class": "2",
   "state": "",
   "country": "DE",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251619",
   "first_seen": "2026-02-13",
   "last_seen": "2026-02-13",
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  {
   "id": "K260130",
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   "parent": "Arbor Endovascular, LLC",
   "device": "Willow 18 Guidewire",
   "category": "Cardiovascular",
   "specialty": "Cardiovascular",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-02-13",
   "date_received": "2026-01-16",
   "product_code": "MOF",
   "device_class": "2",
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   "country": "US",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260130",
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   "parent": "VPIX Medical, Inc.",
   "device": "cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)",
   "category": "Other",
   "specialty": "Gastroenterology, Urology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-02-13",
   "date_received": "2025-06-17",
   "product_code": "OWN",
   "device_class": "2",
   "state": "",
   "country": "KR",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251852",
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   "company": "Joytech Healthcare Co. , Ltd.",
   "parent": "Joytech Healthcare Co. , Ltd.",
   "device": "Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)",
   "category": "Cardiovascular",
   "specialty": "Cardiovascular",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-02-13",
   "date_received": "2025-08-26",
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   "archive_reason": "seeded from FDA historical record"
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   "parent": "Medela, LLC",
   "device": "Motion InBra (YM-8801) wearable breast pump",
   "category": "Women's Health",
   "specialty": "Obstetrics/Gynecology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-02-13",
   "date_received": "2025-09-25",
   "product_code": "HGX",
   "device_class": "2",
   "state": "IL",
   "country": "US",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253149",
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   "parent": "Shenzhen Hingmed Medical Instrument Co., Ltd.",
   "device": "Wearable Ambulatory Blood Pressure Monitor (WBP-02A)",
   "category": "Cardiovascular",
   "specialty": "Cardiovascular",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2026-02-13",
   "date_received": "2025-05-23",
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   "company": "Medtronic, Inc.",
   "parent": "Medtronic",
   "device": "Sprint Quattro Lead (6935M, 6947); Sprint Quattro Lead (6935, 6947M)",
   "category": "Cardiovascular",
   "specialty": "Cardiovascular",
   "status": "Approved (30-day notice)",
   "cleared": true,
   "decision_date": "2026-02-13",
   "date_received": "2026-01-20",
   "product_code": "NVY",
   "device_class": "3",
   "state": "MN",
   "country": "US",
   "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P920015",
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   "pathway": "PMA Supplement",
   "company": "Abbott Vascular",
   "parent": "Abbott",
   "device": "XIENCE Alpine Everolimus Eluting Coronary Stent System; XIENCE Sierra Everolimus Eluting Coronary Stent System; XIENCE P",
   "category": "Cardiovascular",
   "specialty": "Cardiovascular",
   "status": "Approved (30-day notice)",
   "cleared": true,
   "decision_date": "2026-02-13",
   "date_received": "2026-01-16",
   "product_code": "NIQ",
   "device_class": "3",
   "state": "CA",
   "country": "US",
   "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110019",
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   "company": "Abbott Medical",
   "parent": "Abbott",
   "device": "Avant (CDHFA700Q, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800T CDHFA600Q, CDHFA600T); Gallant (CDHFA500Q, CDHFA500T)",
   "category": "Cardiovascular",
   "specialty": "Cardiovascular",
   "status": "Approved (30-day notice)",
   "cleared": true,
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   "date_received": "2026-01-15",
   "product_code": "NIK",
   "device_class": "3",
   "state": "CA",
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   "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030054",
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   "parent": "Boston Scientific",
   "device": "RELIANCE 4-FRONT\u0099/model 0636; RELIANCE 4-FRONT/ model 0662; RELIANCE 4-FRONT/ model 0663 00802526592805 P910073; RELIANC",
   "category": "Cardiovascular",
   "specialty": "Cardiovascular",
   "status": "Approved (30-day notice)",
   "cleared": true,
   "decision_date": "2026-02-13",
   "date_received": "2026-01-26",
   "product_code": "LWS",
   "device_class": "3",
   "state": "MN",
   "country": "US",
   "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
   "review_days": 18,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P910073",
   "first_seen": "2026-02-13",
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  {
   "id": "P010012/S602",
   "pathway": "PMA Supplement",
   "company": "Boston Scientific Corp",
   "parent": "Boston Scientific",
   "device": "ACUITY\u0099 X4 Straight/ model 4671; ACUITY X4 Straight/ model 4672; ACUITY X4 Spiral S/ model 4674; ACUITY X4 Spiral S/ mod",
   "category": "Cardiovascular",
   "specialty": "Cardiovascular",
   "status": "Approved (30-day notice)",
   "cleared": true,
   "decision_date": "2026-02-13",
   "date_received": "2026-01-26",
   "product_code": "NIK",
   "device_class": "3",
   "state": "MN",
   "country": "US",
   "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
   "review_days": 18,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010012",
   "first_seen": "2026-02-13",
   "last_seen": "2026-02-13",
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   "archive_reason": "seeded from FDA historical record"
  },
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   "device": "LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)",
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   "specialty": "General, Plastic Surgery",
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   "specialty": "Clinical Toxicology",
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   "cleared": true,
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   "device": "Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)",
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   "decision_date": "2026-01-30",
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   "parent": "Lucas Lifecare",
   "device": "Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer",
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   "device_class": "2",
   "state": "WI",
   "country": "US",
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   "id": "K253532",
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   "parent": "Spectrum Dynamics Medical, Ltd.",
   "device": "TruSPECT Processing Station",
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   "device": "Celebrace Software",
   "category": "Dental",
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   "parent": "Shenzhen Fansizhe Science and Technology Co., Ltd.",
   "device": "Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)",
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   "product_code": "OHT",
   "device_class": "2",
   "state": "",
   "country": "CN",
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   "specialty": "Anesthesiology",
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   "company": "Taewoong Medical Co., Ltd.",
   "parent": "Taewoong Medical Co., Ltd.",
   "device": "Niti-S Biliary Stent; Niti-S Biliary Slim M Stent",
   "category": "Other",
   "specialty": "Gastroenterology, Urology",
   "status": "Cleared",
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   "country": "KR",
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   "device": "ZipToe\u0099 Hammertoe Fusion System",
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   "cleared": true,
   "decision_date": "2025-12-29",
   "date_received": "2025-09-30",
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   "company": "Guardant Health, Inc.",
   "parent": "Guardant Health, Inc.",
   "device": "Guardant360 CDx",
   "category": "Diagnostics",
   "specialty": "Pathology",
   "status": "Approved (30-day notice)",
   "cleared": true,
   "decision_date": "2025-12-29",
   "date_received": "2025-11-26",
   "product_code": "PQP",
   "device_class": "3",
   "state": "CA",
   "country": "US",
   "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
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   "parent": "Shenzhen Saidi Light Therapy Technology Co., Ltd.",
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   "id": "K253349",
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   "parent": "Light Tree Ventures Europe B.V.",
   "device": "Hair Regrowth Cap (Model: T-119-HRC)",
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   "id": "K253342",
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   "specialty": "General, Plastic Surgery",
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   "date_received": "2025-09-30",
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   "country": "KR",
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   "id": "K253279",
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   "company": "Heat IN A Click, LLC",
   "parent": "Heat IN A Click, LLC",
   "device": "Feather/numiere 05 06 07 (05)",
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   "cleared": true,
   "decision_date": "2025-12-24",
   "date_received": "2025-09-29",
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   "state": "FL",
   "country": "US",
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   "id": "K252633",
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   "company": "Cylite Pty. , Ltd.",
   "parent": "Cylite Pty. , Ltd.",
   "device": "Unity Dx (Udx)",
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   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-12-23",
   "date_received": "2025-08-20",
   "product_code": "OBO",
   "device_class": "2",
   "state": "",
   "country": "AU",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252633",
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   "id": "K250476",
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   "parent": "Paragon Implant Mfg., LLC",
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   "specialty": "Dental",
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   "date_received": "2025-02-19",
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   "country": "US",
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   "id": "K253567",
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   "parent": "Healgen Scientific,, LLC",
   "device": "Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card",
   "category": "Other",
   "specialty": "Clinical Toxicology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-12-23",
   "date_received": "2025-11-17",
   "product_code": "NGL",
   "device_class": "2",
   "state": "TX",
   "country": "US",
   "review_days": 36,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253567",
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   "id": "K253675",
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   "company": "Osteoremedies, LLC",
   "parent": "Osteoremedies, LLC",
   "device": "OsteoRemedies Hip Spacer System",
   "category": "Orthopedic",
   "specialty": "Orthopedic",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-12-23",
   "date_received": "2025-11-21",
   "product_code": "KWL",
   "device_class": "2",
   "state": "TN",
   "country": "US",
   "review_days": 32,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253675",
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  },
  {
   "id": "K253312",
   "pathway": "510(k)",
   "company": "Orangecad Med GmbH",
   "parent": "Orangecad Med GmbH",
   "device": "OrangeCAD Med Abutments",
   "category": "Dental",
   "specialty": "Dental",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-12-23",
   "date_received": "2025-09-30",
   "product_code": "NHA",
   "device_class": "2",
   "state": "",
   "country": "DE",
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   "id": "DEN250032",
   "pathway": "De Novo",
   "company": "DiaSorin, Inc.",
   "parent": "DiaSorin, Inc.",
   "device": "LIAISON\u00ae XL MUREX Anti-HDV (318260); LIAISON\u00ae XL MUREX Control Anti-HDV (318261)",
   "category": "Diagnostics",
   "specialty": "Immunology",
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   "decision_date": "2025-12-23",
   "date_received": "2025-07-30",
   "product_code": "SGW",
   "device_class": "2",
   "state": "MN",
   "country": "US",
   "review_days": 146,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN250032",
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   "id": "K253754",
   "pathway": "510(k)",
   "company": "Philips Consumer Lifestyle B.V.",
   "parent": "Philips",
   "device": "Philips Lumea IPL",
   "category": "Surgical",
   "specialty": "General, Plastic Surgery",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-12-23",
   "date_received": "2025-11-25",
   "product_code": "OHT",
   "device_class": "2",
   "state": "",
   "country": "NL",
   "review_days": 28,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253754",
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   "last_seen": "2025-12-23",
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   "archive_reason": "seeded from FDA historical record"
  },
  {
   "id": "K254163",
   "pathway": "510(k)",
   "company": "Nakanishi, Inc.",
   "parent": "Nakanishi, Inc.",
   "device": "VarioSurg 4",
   "category": "Dental",
   "specialty": "Dental",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-12-23",
   "date_received": "2025-12-22",
   "product_code": "DZI",
   "device_class": "2",
   "state": "",
   "country": "JP",
   "review_days": 1,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254163",
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  },
  {
   "id": "K253281",
   "pathway": "510(k)",
   "company": "Updoc, Inc.",
   "parent": "Updoc, Inc.",
   "device": "UpDoc",
   "category": "Anesthesiology",
   "specialty": "Anesthesiology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-12-23",
   "date_received": "2025-09-29",
   "product_code": "NDC",
   "device_class": "2",
   "state": "CA",
   "country": "US",
   "review_days": 85,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253281",
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  },
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   "id": "K252187",
   "pathway": "510(k)",
   "company": "Aura Medical, LLC",
   "parent": "Aura Medical, LLC",
   "device": "Aura Glide (FC40)",
   "category": "Neurology",
   "specialty": "Neurology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-12-23",
   "date_received": "2025-07-14",
   "product_code": "NFO",
   "device_class": "2",
   "state": "NY",
   "country": "US",
   "review_days": 162,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252187",
   "first_seen": "2025-12-23",
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   "id": "K253217",
   "pathway": "510(k)",
   "company": "Medimaging Integrated Solution, Inc (Miis)",
   "parent": "Medimaging Integrated Solution, Inc (Miis)",
   "device": "MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)",
   "category": "Orthopedic",
   "specialty": "Orthopedic",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-12-23",
   "date_received": "2025-09-29",
   "product_code": "HRX",
   "device_class": "2",
   "state": "",
   "country": "TW",
   "review_days": 85,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253217",
   "first_seen": "2025-12-23",
   "last_seen": "2025-12-23",
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   "archive_reason": "seeded from FDA historical record"
  },
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   "id": "K252145",
   "pathway": "510(k)",
   "company": "Paragon Implant Mfg., LLC",
   "parent": "Paragon Implant Mfg., LLC",
   "device": "GEN5\u0099 and GEN5+\u0099 3.3mmD Dental Implants",
   "category": "Dental",
   "specialty": "Dental",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-12-23",
   "date_received": "2025-07-09",
   "product_code": "DZE",
   "device_class": "2",
   "state": "CA",
   "country": "US",
   "review_days": 167,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252145",
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  },
  {
   "id": "DEN250004",
   "pathway": "De Novo",
   "company": "Hai Solutions",
   "parent": "Hai Solutions",
   "device": "QIKCAP System",
   "category": "General Hospital",
   "specialty": "General Hospital",
   "status": "Granted",
   "cleared": true,
   "decision_date": "2025-12-23",
   "date_received": "2025-01-30",
   "product_code": "SGX",
   "device_class": "2",
   "state": "CA",
   "country": "US",
   "review_days": 327,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN250004",
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  {
   "id": "K253740",
   "pathway": "510(k)",
   "company": "Hong Qiangxing (Shenzhen) Electronics Limited",
   "parent": "Hong Qiangxing (Shenzhen) Electronics Limited",
   "device": "Tens&Ems (Hz9151B, Hz9151C, Hz9151D)",
   "category": "Neurology",
   "specialty": "Neurology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-12-23",
   "date_received": "2025-11-24",
   "product_code": "NUH",
   "device_class": "2",
   "state": "",
   "country": "CN",
   "review_days": 29,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253740",
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   "archive_reason": "seeded from FDA historical record"
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  {
   "id": "K251268",
   "pathway": "510(k)",
   "company": "Edan Instruments, Inc.",
   "parent": "Edan Instruments, Inc.",
   "device": "Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)",
   "category": "Imaging",
   "specialty": "Radiology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-12-23",
   "date_received": "2025-04-24",
   "product_code": "IYN",
   "device_class": "2",
   "state": "",
   "country": "CN",
   "review_days": 243,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251268",
   "first_seen": "2025-12-23",
   "last_seen": "2025-12-23",
   "archived_on": "2026-07-28",
   "archive_reason": "seeded from FDA historical record"
  },
  {
   "id": "K251991",
   "pathway": "510(k)",
   "company": "Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.",
   "parent": "Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.",
   "device": "SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)",
   "category": "General Hospital",
   "specialty": "General Hospital",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-12-23",
   "date_received": "2025-06-27",
   "product_code": "JOJ",
   "device_class": "2",
   "state": "",
   "country": "CN",
   "review_days": 179,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251991",
   "first_seen": "2025-12-23",
   "last_seen": "2025-12-23",
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  },
  {
   "id": "K251800",
   "pathway": "510(k)",
   "company": "Healgen Scientific,, LLC",
   "parent": "Healgen Scientific,, LLC",
   "device": "Healgen\u00ae URS Test Strips",
   "category": "Diagnostics",
   "specialty": "Clinical Chemistry",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-12-23",
   "date_received": "2025-06-12",
   "product_code": "JMT",
   "device_class": "1",
   "state": "TX",
   "country": "US",
   "review_days": 194,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251800",
   "first_seen": "2025-12-23",
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   "archived_on": "2026-07-28",
   "archive_reason": "seeded from FDA historical record"
  },
  {
   "id": "K252835",
   "pathway": "510(k)",
   "company": "Guangdong Prestige Technology Co., Ltd.",
   "parent": "Guangdong Prestige Technology Co., Ltd.",
   "device": "Electric Scooter (S202572J, S2060, M2089, S2050)",
   "category": "Physical Medicine",
   "specialty": "Physical Medicine",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-12-23",
   "date_received": "2025-09-05",
   "product_code": "INI",
   "device_class": "2",
   "state": "",
   "country": "CN",
   "review_days": 109,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252835",
   "first_seen": "2025-12-23",
   "last_seen": "2025-12-23",
   "archived_on": "2026-07-28",
   "archive_reason": "seeded from FDA historical record"
  },
  {
   "id": "K253239",
   "pathway": "510(k)",
   "company": "Signature Orthopaedics Pty, Ltd.",
   "parent": "Signature Orthopaedics Pty, Ltd.",
   "device": "Active-V Total Knee System; World Total Knee System",
   "category": "Orthopedic",
   "specialty": "Orthopedic",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-12-23",
   "date_received": "2025-09-29",
   "product_code": "MBH",
   "device_class": "2",
   "state": "",
   "country": "AU",
   "review_days": 85,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253239",
   "first_seen": "2025-12-23",
   "last_seen": "2025-12-23",
   "archived_on": "2026-07-28",
   "archive_reason": "seeded from FDA historical record"
  },
  {
   "id": "K252146",
   "pathway": "510(k)",
   "company": "Shenzhen Siken 3D Technology Development Co., Ltd.",
   "parent": "Shenzhen Siken 3D Technology Development Co., Ltd.",
   "device": "Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)",
   "category": "Neurology",
   "specialty": "Neurology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-12-23",
   "date_received": "2025-07-09",
   "product_code": "NFO",
   "device_class": "2",
   "state": "",
   "country": "CN",
   "review_days": 167,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252146",
   "first_seen": "2025-12-23",
   "last_seen": "2025-12-23",
   "archived_on": "2026-07-28",
   "archive_reason": "seeded from FDA historical record"
  },
  {
   "id": "K252493",
   "pathway": "510(k)",
   "company": "Hycor Biomedical",
   "parent": "Hycor Biomedical",
   "device": "NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)",
   "category": "Diagnostics",
   "specialty": "Immunology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-12-23",
   "date_received": "2025-08-08",
   "product_code": "DHB",
   "device_class": "2",
   "state": "CA",
   "country": "US",
   "review_days": 137,
   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252493",
   "first_seen": "2025-12-23",
   "last_seen": "2025-12-23",
   "archived_on": "2026-07-28",
   "archive_reason": "seeded from FDA historical record"
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253758",
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   "parent": "Gu'An Yeolight Smart Electronics Co., Ltd.",
   "device": "IPL Hair Removal Device (SYL001AZ, SYL002AZ)",
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   "device": "SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx",
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   "id": "K253423",
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   "company": "Mentor Worldwide, LLC",
   "parent": "Mentor Worldwide, LLC",
   "device": "MENTOR\u0099 Saline-Filled and SPECTRUM\u0099 Breast Implants",
   "category": "Surgical",
   "specialty": "General, Plastic Surgery",
   "status": "Approved",
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   "parent": "Shanghai Lange Medtech Co., Ltd.",
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   "product_code": "QIH",
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   "date_received": "2025-08-07",
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   "parent": "Beckman Coulter, Inc.",
   "device": "Access AFP (on DxI 9000 Analyzer)",
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   "decision_date": "2025-11-03",
   "date_received": "2024-10-24",
   "product_code": "LOK",
   "device_class": "3",
   "state": "CA",
   "country": "US",
   "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
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   "id": "P180027/S013",
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   "device": "Flow Re-Direction Endoluminal Device (FRED\u00ae) System",
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   "product_code": "OUT",
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   "device": "Ceribell Instant EEG Headcap (Small: C251, Medium: C252)",
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   "id": "K253501",
   "pathway": "510(k)",
   "company": "Vigodent Ind\u00fastria E Comercio Ltda",
   "parent": "Vigodent Ind\u00fastria E Comercio Ltda",
   "device": "Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204)",
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   "specialty": "Dental",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-10-31",
   "date_received": "2025-10-30",
   "product_code": "ELW",
   "device_class": "2",
   "state": "",
   "country": "BR",
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   "id": "K250338",
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   "company": "Medacta International S.A.",
   "parent": "Medacta International S.A.",
   "device": "MSS - Humeral reverse liners extension",
   "category": "Orthopedic",
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   "date_received": "2025-02-06",
   "product_code": "PHX",
   "device_class": "2",
   "state": "",
   "country": "CH",
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   "id": "K250917",
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   "company": "Shenzhen Sanping Image Technology Co., Ltd.",
   "parent": "Shenzhen Sanping Image Technology Co., Ltd.",
   "device": "Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)",
   "category": "Other",
   "specialty": "Gastroenterology, Urology",
   "status": "Cleared",
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   "decision_date": "2025-10-31",
   "date_received": "2025-03-27",
   "product_code": "FGB",
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   "country": "CN",
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   "id": "K252442",
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   "parent": "Applied Medical Resources Corp.",
   "device": "Kii Structural Balloon Access System",
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   "specialty": "Gastroenterology, Urology",
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   "company": "Actuated Medical, Inc.",
   "parent": "Actuated Medical, Inc.",
   "device": "GripTract-GI\u0099 Endoscopic Tissue Manipulator Upper GI Model GT-GS100",
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   "specialty": "Gastroenterology, Urology",
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   "decision_date": "2025-10-31",
   "date_received": "2025-04-03",
   "product_code": "FDS",
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   "parent": "Orthofix US, LLC",
   "device": "Firebird SI Navigation System",
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   "parent": "Terrats Medical SL",
   "device": "DESS Dental Smart Solutions",
   "category": "Dental",
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   "decision_date": "2025-10-31",
   "date_received": "2025-05-21",
   "product_code": "NHA",
   "device_class": "2",
   "state": "",
   "country": "ES",
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   "company": "Persyst Development, LLC",
   "parent": "Persyst Development, LLC",
   "device": "Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))",
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   "specialty": "Neurology",
   "status": "Cleared",
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   "decision_date": "2025-10-31",
   "date_received": "2025-07-10",
   "product_code": "OMB",
   "device_class": "2",
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   "id": "K250358",
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   "company": "Becton, Dickinson and Company",
   "parent": "Becton Dickinson",
   "device": "BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System",
   "category": "Diagnostics",
   "specialty": "Microbiology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-10-31",
   "date_received": "2025-02-07",
   "product_code": "PCI",
   "device_class": "2",
   "state": "MD",
   "country": "US",
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   "id": "K252777",
   "pathway": "510(k)",
   "company": "Maxx Orthopedics, Inc.",
   "parent": "Maxx Orthopedics, Inc.",
   "device": "Freedom Metaphyseal Cone Implants (Metaphyseal Cones)",
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   "specialty": "Orthopedic",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-10-31",
   "date_received": "2025-09-02",
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   "country": "US",
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   "id": "K252427",
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   "parent": "Sanhe Meditech Co., Ltd.",
   "device": "Diode Laser Hair Removal Machine (GLD01)",
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   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-10-31",
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   "product_code": "GEX",
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   "state": "",
   "country": "CN",
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   "id": "K250306",
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   "device": "Chex-All Sterilization Pouches and Tubes",
   "category": "General Hospital",
   "specialty": "General Hospital",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-10-31",
   "date_received": "2025-02-03",
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   "state": "NY",
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   "parent": "Phasor Health, LLC",
   "device": "Green",
   "category": "Neurology",
   "specialty": "Neurology",
   "status": "Cleared",
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   "decision_date": "2025-10-31",
   "date_received": "2025-07-01",
   "product_code": "HBE",
   "device_class": "2",
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   "company": "Canon Medical Systems Corporation",
   "parent": "Canon Medical",
   "device": "Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System",
   "category": "Imaging",
   "specialty": "Radiology",
   "status": "Cleared",
   "cleared": true,
   "decision_date": "2025-10-31",
   "date_received": "2025-07-02",
   "product_code": "IYN",
   "device_class": "2",
   "state": "",
   "country": "JP",
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   "id": "DEN240074",
   "pathway": "De Novo",
   "company": "Pulsenmore, Ltd.",
   "parent": "Pulsenmore, Ltd.",
   "device": "Pulsenmore ES",
   "category": "Imaging",
   "specialty": "Radiology",
   "status": "Granted",
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   "device": "Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)",
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   "date_received": "2025-04-03",
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   "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250083",
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   "parent": "Visby Medical, Inc.",
   "device": "Visby Medical Men's Sexual Health Test",
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   "company": "Cochlear Americas",
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   "device": "Nucleus\u00ae 24 Cochlear Implant System",
   "category": "Other",
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   "device": "Mentor MemoryGel\u00ae Breast Implants",
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