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
153265–153288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1984
IMMPULSE THEOPHYLLINE ASSAY REAGENTS
K840758 · LER
Paragon Diagnostics, Inc.
Toxicology · 41d
Cleared Apr 04, 1984
PARAMAX AMMONIA REAGENTT
K840770 · JIF
American Dade
Chemistry · 67d
Cleared Apr 04, 1984
CARBON DIOXIDE REAGENT
K840773 · KHS
American Dade
Chemistry · 56d
Cleared Apr 04, 1984
CARBON DIOXIDE CALIBRATOR I
K840774 · JIT
American Dade
Chemistry · 56d
Cleared Apr 04, 1984
CARBON DIOXIDE CALIBRATOR II
K840775 · JIT
American Dade
Chemistry · 56d
Cleared Apr 04, 1984
PARAMAX CHOLESTEROL REAGENT
K840776 · CHH
American Dade
Chemistry · 56d
Cleared Apr 04, 1984
CREATINE KINASE MB REAGENT
K840783 · CGS
American Dade
Chemistry · 49d
Cleared Apr 04, 1984
S-CAL HEMATOLOGY CALIBRATOR
K840794 · KRY
Coulter Electronics, Inc.
Hematology · 41d
Cleared Apr 04, 1984
SWABZYME-OXIDASE
K840810 · JTO
E-Y Laboratories, Inc.
Microbiology · 61d
Cleared Apr 04, 1984
ENDOTOME PNEUMATIC ORTHOPAEDIC CUT
K840831 · HSZ
Cabot Medical Corp.
Orthopedic · 40d
Cleared Apr 04, 1984
IMMPULSE TOBRAMYCIN ASSAY REAGENTS
K840847 · LCR
Paragon Diagnostics, Inc.
Toxicology · 40d
Cleared Apr 04, 1984
SERATEST RF LATEX DETERMINATION
K840863 · DHR
Seragen Diagnostics, Inc.
Immunology · 40d
Cleared Apr 04, 1984
DIETO CONTAINER FOR ENTERNAL NUTRIT
K840916 · KNT
Gil-Med Industries C/O Kegan & Kegan,...
Gastroenterology & Urology · 35d
Cleared Apr 04, 1984
PHILLY INFANT BOLT
K840999 · GWM
Philadelphia Medical Specialties
Neurology · 26d
Cleared Apr 04, 1984
MANUAL BLOOD CELL COUNTING DEVICE
K841026 · GKM
Instrumentation Laboratory CO
Hematology · 23d
Cleared Apr 04, 1984
BANGORT LIFESTYLE COLOSTOMY POUCHES
K841029 · EXB
Howmedica Corp.
Gastroenterology & Urology · 23d
Cleared Apr 04, 1984
TTI REHABILATATION GYM SYS
K841112 · IPF
Therapeutic Technologies, Inc.
Physical Medicine · 20d
Cleared Apr 04, 1984
GASPAK PLUS DISPOS. HYDROGEN &
K841117 · KZJ
Bd Becton Dickinson Vacutainer...
Microbiology · 20d
Cleared Apr 04, 1984
MUELLER HINTON AGAR W/BLOOD & COFACTOR
K841138 · JTZ
Anaerobe Systems
Microbiology · 19d
Cleared Apr 04, 1984
SICKLE HB ASSAY
K841170 · GHM
Isolab, Inc.
Hematology · 16d
Cleared Apr 04, 1984
GENERAL NUTRIENT BROTH
K841203 · JSG
Smith River Biologicals
Microbiology · 23d
Cleared Apr 04, 1984
NON PROPAGATING TRANSPORT
K841205 · JSM
Smith River Biologicals
Microbiology · 23d
Cleared Apr 04, 1984
SELECTIVE & NON-DIFFERENTIAL
K841210 · JSJ
Smith River Biologicals
Microbiology · 23d
Cleared Apr 04, 1984
SINGLE BIOCHEMICAL TEST
K841212 · JSF
Smith River Biologicals
Microbiology · 23d