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: Cleared only ×
174,955 results
88513–88536 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 1998
POWDER FREE SURGEONS GLOVE
K982586 · KGO
Shiva Medicare , Ltd.
General Hospital · 18d
Cleared Aug 10, 1998
IMMUNOWELL VCA IGM TEST
K973939 · LJN
Genbio
Microbiology · 299d
Cleared Aug 10, 1998
IMMUNOWELL EBV VCA IGG TEST
K973940 · LSE
Genbio
Microbiology · 299d
Cleared Aug 10, 1998
IMMUNOWELL EBNA IGG TEST
K973941 · LLM
Genbio
Microbiology · 299d
Cleared Aug 10, 1998
DIGITAL DOC
K981663 · EIA
Digital Doc, LLC
Dental · 91d
Cleared Aug 10, 1998
PRINCE MEDICAL CEMENT PLUG
K981855 · JDI
Prince Medical, Inc.
Orthopedic · 76d
Cleared Aug 10, 1998
ESTENIA
K982164 · EBF
Kuraray America, Inc.
Dental · 52d
Cleared Aug 10, 1998
ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE)
K982201 · EBF
Foremost Dental Mfg., Inc.
Dental · 49d
Cleared Aug 10, 1998
HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS
K982313 · FZP
Weck Closure Systems
General & Plastic Surgery · 40d
Cleared Aug 10, 1998
CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210
K982415 · DRF
Cordis Webster, Inc.
Cardiovascular · 28d
Cleared Aug 10, 1998
AECD ARRHYTHMIA DETECTION SOFTWARE
K982710 · MKJ
Cardiac Science, Inc.
Cardiovascular · 6d
Cleared Aug 09, 1998
3M DENT II SYSTEM
K981647 · EBF
3M Company
Dental · 90d
Cleared Aug 07, 1998
CONTOR TABLE SURFACE
K973705 · DWJ
Hill-Rom, Inc.
Cardiovascular · 312d
Cleared Aug 07, 1998
INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE...
K974588 · IYN
Rimed , Ltd.
Radiology · 241d
Cleared Aug 07, 1998
MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE
K980016 · MOP
Genzyme Surgical Product (Genzyme...
Cardiovascular · 217d
Cleared Aug 07, 1998
SONOPSY LA SYSTEM
K980423 · IYO
Neovision Corp.
Radiology · 185d
Cleared Aug 07, 1998
EMCEE INTRODUCER SHEATH, DILATOR, OBTURATOR, INTRODUCER SET
K980504 · DYB
Schneider/Namic
Cardiovascular · 179d
Cleared Aug 07, 1998
MEDTRONIC ZUMA GUIDING CATHETER
K981198 · DQY
Medtronics Interventional Vascular
Cardiovascular · 127d
Cleared Aug 07, 1998
STEALTHSTATION SYSTEM DIGITIZER CHANGE
K981686 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 86d
Cleared Aug 07, 1998
IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW
K981790 · IYE
Elekta Oncology Systems, Ltd.
Radiology · 79d
Cleared Aug 07, 1998
POS T-7000
K981805 · HCS
Pos Technologies, Inc.
Neurology · 78d
Cleared Aug 07, 1998
SLEEP MANAGEMENT SYSTEM
K981844 · HCC
Rmp, Inc.
Neurology · 73d
Cleared Aug 07, 1998
LIGHT SABER ASPIRATION NEEDLE
K982018 · FMF
Minrad, Inc.
General Hospital · 60d
Cleared Aug 07, 1998
RETURN ELECTRODE CLAMP SHELL CORD MODEL RC 201
K982130 · GEI
New Deantronics, Ltd.
General & Plastic Surgery · 51d