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
167545–167568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 1980
STERILIZATION PROCESS/BABY BLANKET
K792626 · KME
Procter & Gamble Mfg. Co.
General Hospital · 28d
Cleared Jan 16, 1980
STERILIZATION PROCESS/BULB SYRINGE
K792632
Procter & Gamble Mfg. Co.
Dental · 28d
Cleared Jan 16, 1980
CONCEPTROL/THIN PROPHYLACTICS
K792634 · HIS
Ortho Pharmaceutical Corp.
Obstetrics & Gynecology · 28d
Cleared Jan 16, 1980
LEECO P.A.P. QUANT. DIAGNOSTIC KIT
K792652 · JFH
Leeco Diagnostics, Inc.
Chemistry · 26d
Cleared Jan 16, 1980
SENSI-SLIDE
K792657 · JHJ
Hoffmann-La Roche, Inc.
Chemistry · 21d
Cleared Jan 16, 1980
LEUKOPOR
K792666 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 20d
Cleared Jan 16, 1980
LEUKOCLIP POROS
K792667 · FPX
Beiersdorf, Inc.
General & Plastic Surgery · 20d
Cleared Jan 16, 1980
3 WAY URETHRAL IRRIGATION CATHETER
K792719 · KOD
Vesta, Inc.
Gastroenterology & Urology · 19d
Cleared Jan 11, 1980
ENTERIC-TEK
K792058 · JSS
Flow Laboratories, Inc.
Microbiology · 88d
Cleared Jan 11, 1980
RUBELISA TEST KIT
K792133 · GOK
Microbiological Assoc.
Microbiology · 81d
Cleared Jan 11, 1980
DYE CURVE EVALUATOR
K792135 · DQK
Sci-Pro, Inc.
Cardiovascular · 81d
Cleared Jan 11, 1980
CHEMISTRY ANALYZER REAGENTS
K792482 · CIX
Laboratory Products, Inc.
Chemistry · 53d
Cleared Jan 11, 1980
ACA HIGH DENSITY LIPOPROTEIN CHOLES.
K792509 · CHH
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 37d
Cleared Jan 11, 1980
SANDARE CHLORIDE PROCEDURE
K792531 · CHJ
Sandare Chemical Co., Inc.
Chemistry · 35d
Cleared Jan 11, 1980
GLUCOSE (HEXOKINASE) REAGENT SET
K792532 · CFR
Macomb Chemical Co.
Chemistry · 35d
Cleared Jan 11, 1980
CREATINE PHOSPHOKINASE (CPK) REAGENT SET
K792533 · JHW
Macomb Chemical Co.
Chemistry · 35d
Cleared Jan 11, 1980
THROMBOKINETIC FIBRINOGEN ASSAY
K792563 · KQJ
Bio/Data Corp.
Hematology · 30d
Cleared Jan 11, 1980
CULTURIA MACCONKEY/COLUMBIA CNA
K792579 · JXA
Clinical Convenience Products, Inc.
Microbiology · 28d
Cleared Jan 11, 1980
TERRITIN RIA KIT
K792588 · JMG
Bd Becton Dickinson Vacutainer...
Immunology · 25d
Cleared Jan 11, 1980
AMBU UNIVERSAL SUCTION PUMP
K792592 · JCX
Narco Air-Shields
General & Plastic Surgery · 25d
Cleared Jan 11, 1980
STERILIZATION PROCESS CHANGE BOUNDARY
K792621 · KKX
Procter & Gamble Mfg. Co.
General Hospital · 23d
Cleared Jan 11, 1980
STERILIZATION PROCESS /USE GOWNS
K792622 · FYA
Procter & Gamble Mfg. Co.
General Hospital · 23d
Cleared Jan 11, 1980
STERILIZATION PROCESS/ABSORBENT TOWEL
K792623 · KKX
Procter & Gamble Mfg. Co.
General Hospital · 23d
Cleared Jan 11, 1980
STERILIZATION PROCESS/ MAYO PAD
K792624 · JOJ
Procter & Gamble Mfg. Co.
General Hospital · 23d