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

Filters: Cleared only ×
175,820 results
112225–112248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1993
CA-1000 AUTOMATED COAGULATION ANALYZER
K931149 · JPA
Toa Medical Electronics USA, Inc.
Hematology · 240d
Cleared Nov 03, 1993
ACU-RAY
K931279 · IZL
Sterne Equipment Co., Ltd.
Radiology · 240d
Cleared Nov 03, 1993
RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM
K931372 · ESD
Resound Corp.
Ear, Nose, Throat · 231d
Cleared Nov 03, 1993
DUCERAGOLD, DUCERATIN
K931808 · ELL
Degussa AG
Dental · 205d
Cleared Nov 03, 1993
CAPS
K932012 · ELL
Chemichl, Inc.
Dental · 194d
Cleared Nov 03, 1993
TRACHEOSTOMY CARE TRAY
K932016 · JOH
Clinipad Corp.
Anesthesiology · 194d
Cleared Nov 03, 1993
QL MULTIPULSE 2048
K933299 · JAA
Infimed, Inc.
Radiology · 119d
Cleared Nov 03, 1993
DELTAMANAGER
K933321 · KPS
Medimage, Inc.
Radiology · 110d
Cleared Nov 03, 1993
IMPAX 1000
K933409 · LMD
Heraeus Kulzer, Inc.
Radiology · 114d
Cleared Nov 03, 1993
RAM-PACS
K933493 · IYE
Medical Knowledge Systems, Inc.
Radiology · 107d
Cleared Nov 03, 1993
BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY
K933589 · DDG
Boehringer Mannheim Corp.
Immunology · 100d
Cleared Nov 03, 1993
DYE MANAGEMENT SYSTEM
K933700 · DQO
Abbott Laboratories
Cardiovascular · 97d
Cleared Nov 03, 1993
EP-X
K934481 · JAA
Fischer Imaging Corp.
Radiology · 50d
Cleared Nov 03, 1993
RADASSIST
K934566 · IYE
Diacor, Inc.
Radiology · 43d
Cleared Nov 03, 1993
PRO-FLO SYSTEM WITH INFRA-RED REMOTE CONTROL
K934585 · FCD
Lafayette Pharmaceuticals, Inc.
Radiology · 41d
Cleared Nov 02, 1993
SPRINGFUSOR 10R
K910007 · FRN
Go Medical Industries Pty. , Ltd.
General Hospital · 1035d
Cleared Nov 02, 1993
BUFFALO FILTER REPLACEMENT #BLFS-101/103
K930040 · FYD
Buffalo Filter Co., Inc.
General Hospital · 301d
Cleared Nov 02, 1993
BUFFALO FILTER REPLACEMENT FILTER BST312PF
K930061 · FYD
Buffalo Filter Co., Inc.
General Hospital · 300d
Cleared Nov 02, 1993
SHARPLAN SHARPLASE LATERAL ND:YAG FIBER
K930582 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 271d
Cleared Nov 02, 1993
MULTI-VIEW PROCESSOR (MVP)
K931184 · IZI
Adac Laboratories
Radiology · 238d
Cleared Nov 02, 1993
ECG GATING UNIT
K931392 · LNH
Resonex, Inc.
Radiology · 228d
Cleared Nov 02, 1993
GLASSES
K931451 · HQY
Siegel Optik
Ophthalmic · 224d
Cleared Nov 02, 1993
BURRON CARDIOVASCULAR ANGESTAT(TM)
K931743 · DYB
B.Braun Medical, Inc.
Cardiovascular · 209d
Cleared Nov 02, 1993
THORACOSCOPE/LAPAROSCOPE
K931954 · GCM
Surgical Technologies, Inc.
Gastroenterology & Urology · 196d