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
122593–122616 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 1991
VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION
K910666 · JSP
Vitek Systems, Inc.
Microbiology · 51d
Cleared Apr 03, 1991
IL THEOPHYLLINE ASSAY SYSTEM
K910697 · KLS
Instrumentation Laboratory CO
Chemistry · 43d
Cleared Apr 03, 1991
LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2
K910829 · LAS
Bio-Rad
Toxicology · 35d
Cleared Apr 03, 1991
TARGET(TM) CANNABINOIDS-V TEST
K910892 · LDJ
V-Tech, Inc.
Toxicology · 30d
Cleared Apr 03, 1991
TARGET(TM) CANNABINOIDS-R TEST
K910893 · LDJ
V-Tech, Inc.
Toxicology · 30d
Cleared Apr 03, 1991
DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD
K911056 · DIP
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 26d
Cleared Apr 03, 1991
CIBA CORNING ACS CKMB IMMUNOASSAY
K911121 · JHX
Ciba Corning Diagnostics Corp.
Chemistry · 22d
Cleared Apr 03, 1991
RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 9004
K911267 · IXR
Tri W-G, Inc.
Radiology · 23d
Cleared Apr 02, 1991
SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT
K902227 · LIF
Serim Research Corp.
Gastroenterology & Urology · 320d
Cleared Apr 02, 1991
CONDOR ANALOG INFLATION SYRINGE
K904508 · MAV
Professional Medical Services
Cardiovascular · 180d
Cleared Apr 02, 1991
BIVONA ENDOTRACHEAL TUBE STYLET
K905052 · BSR
Bivona Medical Technologies
Anesthesiology · 145d
Cleared Apr 02, 1991
OCHSNER 500 VASCULAR PROSTHESIS
K905269 · DSY
Intervascular, Inc.
Cardiovascular · 130d
Cleared Apr 02, 1991
AUTOGENESIS(TM) AUTOMATOR
K905514 · KTT
Advanced Biosearch Assn.
Orthopedic · 116d
Cleared Apr 02, 1991
CANNULA INTRODUCTION SET
K910015 · HET
Lazarus Medical, Inc.
Obstetrics & Gynecology · 90d
Cleared Apr 02, 1991
MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT
K910022 · FCM
Medical Marketing Group
Gastroenterology & Urology · 89d
Cleared Apr 02, 1991
MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM
K910217 · FAP
Browne Medical Systems, Inc.
Gastroenterology & Urology · 75d
Cleared Apr 02, 1991
BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP
K910285 · FAP
Browne Medical Systems, Inc.
Gastroenterology & Urology · 70d
Cleared Apr 02, 1991
WILSON COOK WIRE GUIDE AND PROTECTIVE GUIDE
K910497 · OCY
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 02, 1991
HEXIDIS ALCOHOL SWAB
K910735 · LKB
Specialites Septodont
General Hospital · 40d
Cleared Apr 02, 1991
SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M
K910783 · BWN
Smith & Nephew Equipment Group
General & Plastic Surgery · 36d
Cleared Apr 02, 1991
BILIARY BALLOON DILATATION CATHETER
K910931 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Apr 02, 1991
MEDIFIL
K910944 · KGN
Biocore
General & Plastic Surgery · 27d
Cleared Apr 01, 1991
KINEMAX SUPERSTABILIZER TOTAL KNEE SYSTEM
K904208 · JWH
Howmedica Corp.
Orthopedic · 201d
Cleared Apr 01, 1991
ENTREE SHEATH INTRODUCER SYSTEM
K904475 · DYB
Cordis Corp.
Cardiovascular · 182d