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
166345–166368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 1980
CAMLOC SYRINGE BIOPSY KIT
K801304 · GEE
Johannah Medical Services, Inc.
General & Plastic Surgery · 9d
Cleared Jun 17, 1980
BURRON MULTI-AD SYRINGE CAP
K801311 · FMF
Burron Medical Products, Inc.
General Hospital · 14d
Cleared Jun 17, 1980
THE PROTECTORS
K801312
Cooper Medical Devices Corp.
General & Plastic Surgery · 14d
Cleared Jun 17, 1980
AO STYLET LARYNGOSCOPE MODEL SLS
K801364 · CAL
American Optical Corp.
Anesthesiology · 7d
Cleared Jun 17, 1980
ECA CREAM REFORMULATION
K801383 · GYB
Vanaray Laboratories, Inc.
Neurology · 6d
Cleared Jun 09, 1980
BUN-COLOR 2, BLOOD UREA NITROGEN TEST
K800902 · CDL
Sclavo, Inc.
Chemistry · 52d
Cleared Jun 09, 1980
J.T. BAKER LSA 290 PIPETTER/DILUTER
K801090 · JQW
J.T. Baker Chemical Co.
Chemistry · 32d
Cleared Jun 09, 1980
K 750 COMPUTER/DATA PROCESSOR
K801091 · JQP
J.T. Baker Chemical Co.
Chemistry · 32d
Cleared Jun 09, 1980
SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL
K801094 · KWH
Dow Corning Corp. Healthcare...
Orthopedic · 32d
Cleared Jun 09, 1980
PERKIN ELMER MODEL 91 AMYLASE REAGENT
K801096 · KHM
Stat Engineering
Chemistry · 31d
Cleared Jun 09, 1980
THYROXINE RADIOIMMUNOASSAY KIT
K801105 · CDX
Calbiochem-Behring Corp.
Chemistry · 31d
Cleared Jun 09, 1980
COBAS TOTAL BILIRUBIN REAGENT & DILUENT
K801117 · CIG
Roche Analytical Instruments, Inc.
Chemistry · 28d
Cleared Jun 09, 1980
COBAS REAGENT FOR ALT (GPT)
K801119 · CKA
Roche Analytical Instruments, Inc.
Chemistry · 28d
Cleared Jun 09, 1980
TRIIODOTHYRONINE RADIOIMMUN. SYSTEM
K801123 · CDP
Calbiochem-Behring Corp.
Chemistry · 28d
Cleared Jun 09, 1980
SPAC T3 RIA TEST KIT
K801125 · CDP
Mallinckrodt Critical Care
Chemistry · 28d
Cleared Jun 09, 1980
CENTRIFICHEM SYSTEM 500 ANALYZER
K801139 · JJG
Union Carbide Corp.
Chemistry · 27d
Cleared Jun 09, 1980
ETHOX/BARRON FOOD PUMP GAVAGE BAG SETS
K801144 · FHT
Ethox Corp.
Gastroenterology & Urology · 27d
Cleared Jun 09, 1980
SMI MULTI-TUBE VORTEXER
K801145 · JRQ
Scientific Manufacturing Industries
Chemistry · 27d
Cleared Jun 09, 1980
HEMOGASTAT
K801148 · JRR
Therapac, Inc.
Hematology · 27d
Cleared Jun 09, 1980
TECHNICON H6000 HEMATOLOGY SYSTEM
K801155 · GKL
Technicon Instruments Corp.
Hematology · 26d
Cleared Jun 09, 1980
CENTRIFICHEM SYSTEM 400
K801167 · JQP
Union Carbide Corp.
Chemistry · 25d
Cleared Jun 09, 1980
CONPHAR DELUXE ANEROID SPHYGMOMANOMETER
K801186 · DXQ
Conphar, Inc.
Cardiovascular · 21d
Cleared Jun 09, 1980
CONPHAR CHECKMATE SPHYGMOMANOMETER
K801187 · DXN
Conphar, Inc.
Cardiovascular · 21d
Cleared Jun 09, 1980
CONPHAR DESK TOP MERCURY SPHYGMOMAN
K801188 · DXQ
Conphar, Inc.
Cardiovascular · 21d