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
109465–109488 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 1994
PANOJECT MINIFUSOR MODEL 100 AMBULATORY INFUSION
K930494 · FRN
Elan Medical Technologies, Ltd.
General Hospital · 449d
Cleared Apr 26, 1994
PANOJECT MINIFUSOR MODEL 200 AMBU. INFUSION PUMP
K930495 · FRN
Elan Medical Technologies, Ltd.
General Hospital · 449d
Cleared Apr 26, 1994
EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY
K931520 · LJN
Mrl Diagnostics
Microbiology · 396d
Cleared Apr 26, 1994
ITI DISTANCE SYSTEM
K931993 · DZE
The Straumann Co.
Dental · 368d
Cleared Apr 26, 1994
BONE ANCHOR FOR SOFT TISSUE ATTACHMENT
K932925 · JDR
Vesitec Medical, Inc.
Orthopedic · 315d
Cleared Apr 26, 1994
EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER
K933869 · FPB
Baxter Healthcare Corp
General Hospital · 260d
Cleared Apr 26, 1994
TAPERED ABUTMENT AND RELATED COMPONENTS
K933969 · DZE
Implant Innovations, Inc.
Dental · 253d
Cleared Apr 26, 1994
RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT
K934013 · CIN
Isolab, Inc.
Chemistry · 251d
Cleared Apr 26, 1994
BECKMAN DIRECT BILIRUBIN REAGENT
K934068 · CIG
Beckman-Diagnostic Systems Group
Chemistry · 249d
Cleared Apr 26, 1994
ERBOKRYO CA CRYOSURGICAL SYSTEM
K934261 · GEH
Erbe Elektromedizin GmbH
General & Plastic Surgery · 238d
Cleared Apr 26, 1994
PARAMAX ALCOHOL REAGENT
K934275 · DIC
Baxter Diagnostics, Inc.
Toxicology · 238d
Cleared Apr 26, 1994
CEDIA DAU CONTROLS
K934650 · DIF
Medical Analysis Systems, Inc.
Toxicology · 209d
Cleared Apr 26, 1994
ARC
K934669 · BSZ
Medelec , Ltd.
Anesthesiology · 209d
Cleared Apr 26, 1994
BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR
K934925 · JIF
Beckman Instruments, Inc.
Chemistry · 193d
Cleared Apr 26, 1994
EML 100
K935120 · JGS
Radiometer America, Inc.
Chemistry · 181d
Cleared Apr 26, 1994
CLOSTRIDIUM DIFFICILE TOX-B TEST
K935296 · LLH
Techlab, Inc.
Microbiology · 174d
Cleared Apr 26, 1994
ANGIOGRAPHIC BALLOON CATHETER BY J-LLOYD
K935402 · DQO
J-Lloyd Medical, Inc.
Cardiovascular · 168d
Cleared Apr 26, 1994
METRONIC BUCHBINDER ENVOY PERCUTANEOUS CATHETERS
K935425 · DQY
Medtronics Interventional Vascular
Cardiovascular · 167d
Cleared Apr 26, 1994
NANOSEP N10
K935496 · JJH
Intersep , Ltd.
Chemistry · 162d
Cleared Apr 26, 1994
MULTICHECK(TM)
K935515 · JJS
Radiometer America, Inc.
Chemistry · 162d
Cleared Apr 26, 1994
SYNERMED IR 500 CHEMISTRY ANALYZER
K935662 · JIQ
Synermed, Inc.
Chemistry · 151d
Cleared Apr 26, 1994
PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP
K935666 · KIE
The Perkin-Elmer Corp.
Toxicology · 151d
Cleared Apr 26, 1994
DYNATRON 150
K935728 · IMG
Dynatronics Corp.
Physical Medicine · 146d
Cleared Apr 26, 1994
IMMULITE DHEA-S04
K935806 · JKC
Diagnostic Products Corp.
Chemistry · 145d