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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
123649–123672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 1990
DIOLASE
K904753 · IWE
Scanditronix, Inc.
Radiology · 21d
Cleared Nov 09, 1990
KODATROL I AND II CONTROL AND DILUENT SET
K904768 · JJY
Eastman Kodak Company
Chemistry · 18d
Cleared Nov 08, 1990
FASTIDIOUS MIC PANEL
K901598 · JWY
Microtech Medical Systems, Inc.
Microbiology · 217d
Cleared Nov 08, 1990
TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS
K901659 · DTK
Boston Scientific Corp
Cardiovascular · 212d
Cleared Nov 08, 1990
BIOPSY NEEDLE TRANSPONDER SYSTEM
K902214 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 176d
Cleared Nov 08, 1990
ELVI 828 DIGICLOT MULTISCAN
K902614 · KQG
Logos Scientific, Inc.
Hematology · 148d
Cleared Nov 08, 1990
LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN
K903221 · DTB
Telectronics Pacing Systems, Inc.
Cardiovascular · 108d
Cleared Nov 08, 1990
VIALON OBTURATOR
K904121 · FOZ
Deseret Medical, Inc.
General Hospital · 63d
Cleared Nov 08, 1990
APTT REAGENT
K904341 · GFO
Sigma Chemical Co.
Hematology · 49d
Cleared Nov 08, 1990
PATIENT EXAMINATION GLOVES
K904936 · LYY
Slim River Latex Sdn. Bhd.
General Hospital · 7d
Cleared Nov 07, 1990
WILSON-COOK VARICES TAMPONADE BALLOON CUFF
K902099 · KNT
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 183d
Cleared Nov 07, 1990
G.E. FLUOROCON 300 IMAGING SYSTEM
K902981 · JAA
Electromek Diagnostic Systems, Inc.
Radiology · 134d
Cleared Nov 07, 1990
BEAMVIEW & BEAMVIEW PLUS (AKA PROJECT 743)
K903139 · IYE
Siemens Medical Laboratories, Inc.
Radiology · 113d
Cleared Nov 07, 1990
VALVE CONTROLLER FOR MICROMACRO COMPOUNDER
K903159 · LHI
Baxa Corp., Sub. of Cook Group, Inc.
General Hospital · 112d
Cleared Nov 07, 1990
HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE)
K903613 · FLE
Harvard Apparatus, Inc.
General Hospital · 90d
Cleared Nov 07, 1990
MODEL600 UTERINE ACTIVITY MONITOR
K903623 · HFM
Corometrics Medical Systems, Inc.
Obstetrics & Gynecology · 90d
Cleared Nov 07, 1990
DOPPLER NEEDLE AND FLOW MONITOR
K903625 · DPW
Peripheral Systems Group
Cardiovascular · 89d
Cleared Nov 07, 1990
XPRESS
K903701 · JAK
Toshiba America Medical Systems, In.C
Radiology · 84d
Cleared Nov 07, 1990
URETERAL BALLOON DILATATION CATHETER
K903813 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 79d
Cleared Nov 07, 1990
PSC-1 W/OTHER NUMERICAL
K903821 · JAA
Eigen
Radiology · 79d
Cleared Nov 07, 1990
LASERSAT CO2
K904067 · GEX
Satelec
General & Plastic Surgery · 68d
Cleared Nov 07, 1990
BUCCAL TUBE, BUCCAL ATTACHMENT
K904093 · EJF
Lancer Orthodontics, Inc.
Dental · 62d
Cleared Nov 07, 1990
STERILE SURGEONS GLOVES (ULTRA-TOUCH-LATEX)
K904320 · KGO
R.K.F. Laboratories, Inc.
General Hospital · 48d
Cleared Nov 07, 1990
CIBA CORNING ACS PROLACTIN IMMUNOASSAY
K904714 · CFT
Ciba Corning Diagnostics Corp.
Chemistry · 20d