FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: 2023–2023 ×
3,347 results
3337–3347 of 3,347
Search insights Median review: 139d Cleared: 99% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Orthopedic
Cleared Jan 04, 2023
DEKA HELIX
K222221 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 163d
Cleared Jan 04, 2023
Radial Artery Compression Tourniquets
K222182 · DXC
Beijing Demax Medical Technology Co.,Ltd
Cardiovascular · 166d
Cleared Jan 04, 2023
Wearable Breast Pump (Model S1DW)
K222045 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 177d
Cleared Jan 04, 2023
Elecsys Anti-HCV II (08837031190)
K221693 · MZO
Roche Diagnostics
Microbiology · 208d
Cleared Jan 04, 2023
Steriking LT-Blueline Pouches with Tyvek
K221379 · FRG
Wipak OY
General Hospital · 237d
Cleared Jan 04, 2023
SilentCloud
K221125 · KLW
Aureliym GmbH
Ear, Nose, Throat · 261d
Cleared Jan 04, 2023
OnyxCeph
K213263 · LLZ
Image Instruments GmbH
Dental · 461d
Cleared Jan 03, 2023
EZ-STIK Electrodes
K223775 · GXY
South Dakota Partners
Neurology · 18d
Cleared Jan 03, 2023
3.0T 16ch AIR AA
K223378 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 57d
Cleared Jan 03, 2023
Medical Disposable Face Masks
K222809 · FXX
Anqing Mayfield Medical Limited
General Hospital · 109d
Cleared Jan 03, 2023
AETOS Shoulder System
K220847 · KWS
Smith & Nephew, Inc.
Orthopedic · 286d