FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
10321–10344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 2023
SafeBreak® Vascular
K223486 · QOI
Lineus Medical
General Hospital · 179d
Cleared May 19, 2023
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W
K222979 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 233d
Cleared May 19, 2023
Ventana™ C Spinal System
K222833 · ODP
Spinal Elements, Inc.
Orthopedic · 241d
Cleared May 19, 2023
ATTO Mobility Scooter (ATTO)
K222703 · INI
Moving Life, Ltd.
Physical Medicine · 254d
Cleared May 19, 2023
Disposable Medical Mask
K222545 · FXX
Guangzhou Fuzelong Hygiene Material...
General Hospital · 270d
Cleared May 19, 2023
Exactech® Alteon® Short Tapered Wedge
K221323 · LZO
Exactech, Inc.
Orthopedic · 378d
Cleared May 19, 2023
iLet® Dosing Decision Software
K220916 · QJI
Beta Bionics, Inc.
Chemistry · 415d
Cleared May 19, 2023
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors,...
K220842 · KFM
Qura S.R.L
Cardiovascular · 422d
Cleared May 19, 2023
VirtuOst
K220402 · KGI
O.N. Diagnostics
Radiology · 462d
Cleared May 19, 2023
Autoplaque
K212758 · LLZ
Cedars-Sinai Medical Center: Aim
Radiology · 626d
Cleared May 18, 2023
Arthrex FiberTak Suture Anchor
K231113 · MBI
Arthrex, Inc.
Orthopedic · 29d
Cleared May 18, 2023
uMR 570
K230758 · LNH
Shanghai United Imaging Healthcare...
Radiology · 59d
Cleared May 18, 2023
C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor
K230723 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 63d
Cleared May 18, 2023
ComASP Cefiderocol 0.008-128
K230479 · JWY
Liofilchem S. R. L.
Microbiology · 85d
Cleared May 18, 2023
OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging...
K230453 · OBJ
Boston Scientific Corporation
Cardiovascular · 86d
Cleared May 18, 2023
Single Use Bipolar Forceps
K230432 · GEI
Hg Innovations, Ltd.
General & Plastic Surgery · 90d
Cleared May 18, 2023
Single-Use Flexible Ureteroscope
K230200 · FGB
Hunan Vathin Medical Instrument Co.,...
Gastroenterology & Urology · 113d
Cleared May 18, 2023
Restrata® MiniMatrix
K223725 · QSZ
Acera Surgical, Inc.
General & Plastic Surgery · 156d
Cleared May 18, 2023
I.V. Administration Set, I.V. Extension Set
K223645 · FPA
Bq Plus Medical Co., Ltd.
General Hospital · 163d
Cleared May 18, 2023
Anchor Bolts as Accessories to Depth Electrodes
K223276 · GZL
Ad-Tech Medical Instrument Corporation
Neurology · 206d
Cleared May 18, 2023
Spencer Probe Depth Electrodes
K223269 · GZL
Ad-Tech Medical Instrument Corporation
Neurology · 206d
Cleared May 18, 2023
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
K222578 · KKX
3M Company
General Hospital · 266d
Cleared May 18, 2023
Claritag Advanced
K222356 · GEH
Dgi Technologies
General & Plastic Surgery · 287d
Cleared May 18, 2023
Endo Motor
K220829 · EKX
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 422d