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
149449–149472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 1985
ROTALOK SURGICAL HAND TABLE
K850251
Fairleigh Dickinson Laboratories, Inc.
General & Plastic Surgery · 37d
Cleared Feb 28, 1985
GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY
K850285 · KOD
Premium Plastics, Inc.
Gastroenterology & Urology · 36d
Cleared Feb 28, 1985
MENTOR PERCUTANEOUS COIL NEPHROSTOMY SET
K850286 · LJE
Mentor Corp.
Gastroenterology & Urology · 35d
Cleared Feb 28, 1985
ELECTROSURGICAL PENCIL HOLDER 720
K850297 · GEI
Birtcher Corp.
General & Plastic Surgery · 35d
Cleared Feb 28, 1985
GYNASPYR VACUUM CURETTAGE UNIT
K850312 · HHI
Roseburg SA
Obstetrics & Gynecology · 34d
Cleared Feb 28, 1985
SUNSHOWER MODEL HU-01-12L
K850493 · FTC
Sunthetic Engineering, Inc.
General & Plastic Surgery · 20d
Cleared Feb 27, 1985
LASER PROTECTIVE EYESHIELD
K833679
Stefanovsky & Assoc.
General & Plastic Surgery · 540d
Cleared Feb 27, 1985
XANAR MODEL XSE-300 SMOKE EVACULATER
K844087 · FYD
Xanar, Inc.
General Hospital · 128d
Cleared Feb 27, 1985
ULTROSER G
K844413 · JJY
Lkb Instruments, Inc.
Chemistry · 105d
Cleared Feb 27, 1985
COAT-A-COUNT FREE TESTOSTERONE KIT & COMPONENTS
K844423 · CDZ
Diagnostic Products Corp.
Chemistry · 104d
Cleared Feb 27, 1985
AUSTENAL A-79 CROWN & BRIDGE CASTING ALLOY
K844497 · EJH
Austenal Dental, Inc.
Dental · 99d
Cleared Feb 27, 1985
INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM
K844771 · LHQ
Image Systems, Inc.
Radiology · 82d
Cleared Feb 27, 1985
INHIBITORY MOLD AGAR
K844929 · JSJ
American Laboratory Supply, Inc.
Microbiology · 70d
Cleared Feb 27, 1985
BRILLANT GREEN AGAR
K844930 · JSI
American Laboratory Supply, Inc.
Microbiology · 70d
Cleared Feb 27, 1985
MYCOLOGICAL AGAR W/ANTIBIOTICS
K844931 · JSJ
American Laboratory Supply, Inc.
Microbiology · 70d
Cleared Feb 27, 1985
MALT AGAR
K844932 · JSJ
American Laboratory Supply, Inc.
Microbiology · 70d
Cleared Feb 27, 1985
BILE ESCULIN AGAR
K844933 · JSI
American Laboratory Supply, Inc.
Microbiology · 70d
Cleared Feb 27, 1985
NUTRIENT MIXTURE F-10 -HAM, N 1387, W/L-GLUTAMINE
K845012 · KIT
Sigma Chemical Co.
Pathology · 63d
Cleared Feb 27, 1985
RPMI-1640 MED. W/L-GLUTAMINE & 25MM HEPES & W/O SO
K845013 · KIT
Sigma Chemical Co.
Pathology · 63d
Cleared Feb 27, 1985
MED. 199 W/EARLE'S SALTS, L-GLUTAMINE & 25MM HEPES
K845014 · KIT
Sigma Chemical Co.
Pathology · 63d
Cleared Feb 27, 1985
DISPOSABLE ECG ELECTRODES EASATRACE
K850085 · DRX
Medical Device Marketing
Cardiovascular · 47d
Cleared Feb 27, 1985
MINIMUM ESSENTIAL MED. (MEM) W/EARLE'S SALS L-GLUT
K850089 · KIT
Sigma Chemical Co.
Pathology · 47d
Cleared Feb 27, 1985
DULBECCO'S MODIFIED EAGLE'S MED. (DME) W/1000 MG/L
K850090 · KIT
Sigma Chemical Co.
Pathology · 47d
Cleared Feb 27, 1985
BASAL MED. EAGLE(BME) W/EARLE'S SALTS, L-GLUTAMINE
K850091 · KIT
Sigma Chemical Co.
Pathology · 47d