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
15865–15888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 2021
Avaira Vitality
K213164 · LPL
CooperVision, Inc.
Ophthalmic · 28d
Cleared Oct 26, 2021
Thrombuster II Aspiration Catheter
K213166 · QEZ
Kaneka Medical America, LLC
Cardiovascular · 28d
Cleared Oct 25, 2021
Best Glove-Nitrile Powder Free Examination Glove
K210249 · LZA
Bestsafe Glove Co., Ltd.
General Hospital · 269d
Cleared Oct 25, 2021
Ultrasonic Surgical & Electrosurgical Generator
K210488 · GEI
Surgnova Healthcare Technologies...
General & Plastic Surgery · 248d
Cleared Oct 25, 2021
Arthrex LoopLoc Knotless Suture
K212146 · GAT
Arthrex, Inc.
General & Plastic Surgery · 108d
Cleared Oct 25, 2021
Advanced Algorithms for Treatment Management Applications (AATMA)
K212218 · QKB
Elekta Solutions AB
Radiology · 101d
Cleared Oct 25, 2021
Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A)
K212293 · FXX
Jiangmen Ningrui Medical Supplies...
General Hospital · 95d
Cleared Oct 25, 2021
Disposable Nitrile Examination Glove
K212401 · LZA
Inner Mongolia Cureguard Medical...
General Hospital · 84d
Cleared Oct 25, 2021
Laser Treatment System, Model: Hera, Armo
K212793 · GEX
Canadian Pioneer Medical Technology...
General & Plastic Surgery · 54d
Cleared Oct 25, 2021
Introcan Safety 3 Closed IV Catheter
K213085 · FOZ
B.Braun Medical, Inc.
General Hospital · 31d
Cleared Oct 25, 2021
Titan Manufacturing Bipolar Forceps
K213386 · GEI
Titan Manufacturing, Inc.
General & Plastic Surgery · 12d
Cleared Oct 24, 2021
Disposable Medical Surgical Mask
K210348 · FXX
Weihai Dishang Medical Technology...
General Hospital · 258d
Cleared Oct 24, 2021
Surgical Gown
K211509 · FYA
Hubei Wanli Protective Products Co.,...
General Hospital · 163d
Cleared Oct 24, 2021
Vinyl Examination Gloves(Yellow)
K211698 · LYZ
Liuping Trading Co., Ltd.
General Hospital · 143d
Cleared Oct 24, 2021
Surgical Face Mask
K212368 · FXX
Anhui Tiankang Medical Technology...
General Hospital · 86d
Cleared Oct 22, 2021
P300 Attachment
K202120 · HBE
Nakanishi, Inc.
Neurology · 449d
Cleared Oct 22, 2021
CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit
K210310 · GEH
Nuance Medical, LLC
General & Plastic Surgery · 261d
Cleared Oct 22, 2021
Quantum Anterior Cervical Plate
K210424 · KWQ
Nvision Biomedical Technologies, Inc.
Orthopedic · 253d
Cleared Oct 22, 2021
FlightPlan for Liver
K210807 · LLZ
GE Medical Systems SCS
Radiology · 219d
Cleared Oct 22, 2021
Erchonia XLR8
K211186 · NHN
Erchonia Corporation
Physical Medicine · 185d
Cleared Oct 22, 2021
CO2 Laser Machine, Model: BW-203B
K211735 · GEX
Zhengzhou Bestview ST Co., Ltd.
General & Plastic Surgery · 137d
Cleared Oct 22, 2021
Cohitech Organic Cotton Non-Applicator Cottonlock Tampons
K211775 · HEB
Cotton High Tech S.L.
Obstetrics & Gynecology · 135d
Cleared Oct 22, 2021
DiLumen C2 and Tool Mount
K211819 · FDF
Lumendi, LLC
Gastroenterology & Urology · 133d
Cleared Oct 22, 2021
EnSite X EP System
K212061 · DQK
Abbott
Cardiovascular · 113d