FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
145–168 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 2026
Biolinq Shine Autonomous Time-in-Range Microsensor
K262599 · SFU
Biolinq Incorporated
Chemistry · 53d
Cleared Sep 18, 2026
NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501,...
K262532 · LGZ
Icu Medical
General Hospital · 58d
Cleared Sep 18, 2026
Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice...
K262524 · OHT
ONE BEAUTY Technology Co., Ltd.
General & Plastic Surgery · 58d
Cleared Sep 18, 2026
Pathfinder Endoscope Overtube
K262262 · FED
Neptune Medical, Inc.
Gastroenterology & Urology · 78d
Cleared Sep 18, 2026
EnHAnce PEEK Bunion System
K262098 · HRS
Nvision Biomedical Technologies
Orthopedic · 88d
Cleared Sep 18, 2026
Elucid PlaqueIQ
K261855 · LLZ
Elucid Bioimaging, Inc.
Radiology · 107d
Cleared Sep 18, 2026
SCENARIA View Phase 6.0
K261229 · JAK
Fujifilm Corporation
Radiology · 156d
Cleared Sep 18, 2026
UNIDRIVE Select System
K261102 · HIH
Karl Storz SE & CO. KG
Obstetrics & Gynecology · 168d
Cleared Sep 18, 2026
Dental Diode Laser Device (Laser-Pen)
K261047 · GEX
Guilin Kevin Peter Technology Co., Ltd.
Dental · 171d
Cleared Sep 18, 2026
Deterioration Index Version 2
K260008 · QNL
Epic Systems Corporation
Cardiovascular · 259d
Cleared Sep 18, 2026
MINT MONO Sutures
K254238 · NEW
Hans Biomed Corporation
General & Plastic Surgery · 263d
Cleared Sep 18, 2026
Drainage Catheter
K254179 · FGE
Canyon Medical, Inc.
Gastroenterology & Urology · 269d
Cleared Sep 18, 2026
Mesh Nebulizer (UN204)
K254171 · CAF
Shenzhen Mericonn Technology Co., Ltd.
Anesthesiology · 269d
Cleared Sep 18, 2026
VacHeal Negative Pressure Wound Therapy System
K254160 · OKO
VacHeal, LLC
General & Plastic Surgery · 270d
Cleared Sep 18, 2026
25G Huber Needle
K254095 · PTI
Martech Medical Products
General Hospital · 273d
Cleared Sep 18, 2026
Triever Duo Catheter
K253419 · QEW
Inari Medical, Inc.
Cardiovascular · 352d
Cleared Sep 18, 2026
Hyperdrive 35 Guidewire
K253146 · DQX
Rapid Medical , Ltd.
Cardiovascular · 358d
Cleared Sep 17, 2026
Protégé™ EverFlex™ Self-expanding Peripheral Stent System
K262913 · FGE
Medtronic, Inc.
Gastroenterology & Urology · 29d
Cleared Sep 17, 2026
Miru 1day UpSide (midafilcon A)
K262495 · LPL
Menicon Co, Ltd.
Ophthalmic · 59d
Cleared Sep 17, 2026
FRAXION Spinal Fixation System
K262091 · NKB
Ortler Global Tibbi Gerecler Anonim...
Orthopedic · 87d
Cleared Sep 17, 2026
Hygienic Protective Bite Cover (2207-010-50)
K262073 · PEM
D?rr Dental SE
Dental · 87d
Cleared Sep 17, 2026
Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade,...
K261959 · GEI
Stryker Instruments
General & Plastic Surgery · 98d
Cleared Sep 17, 2026
Integrity Retractable Implant Inserter (6000127)
K261869 · MBI
Anika Therapeutics, Inc.
Orthopedic · 105d
Cleared Sep 17, 2026
Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)
K261817 · GEX
Zhengzhou PZ Laser Slim Technology...
General & Plastic Surgery · 108d