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
163417–163440 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 29, 1981
MYCOSEL
K811334 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 17d
Cleared May 29, 1981
THIOGLYCOLLATE GELATIN MEDIUM
K811335 · JSH
Acumedia Manufacturers, Inc.
Microbiology · 17d
Cleared May 29, 1981
M-GREEN YEAST & MOLD BROTH
K811336 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 17d
Cleared May 29, 1981
TERGITOL 7 AGAR
K811337 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 17d
Cleared May 29, 1981
VIOLET RED BILE AGAR
K811338 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 17d
Cleared May 29, 1981
TODD HEWITT BROTH
K811339 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 17d
Cleared May 29, 1981
THIOGLYCOLLATE MEDIUM W/OUT INDICATOR
K811340 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 17d
Cleared May 29, 1981
CARDIOPULMONARY BYPASS ACCESSORY EQUIP.
K811348 · KRI
Bentley Laboratories, Inc.
Cardiovascular · 16d
Cleared May 29, 1981
BRAIN HEART INFUSION W/O DEXTROSE
K811353 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 15d
Cleared May 29, 1981
GN BROTH (HAJNA)
K811354 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 15d
Cleared May 29, 1981
LYSINE IRON AGAR
K811355 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 15d
Cleared May 29, 1981
TRYPTONE AZOLECITHIN TWEEN
K811356 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 15d
Cleared May 29, 1981
HEMOGLOBIN POWDER
K811357 · JSK
Acumedia Manufacturers, Inc.
Microbiology · 15d
Cleared May 29, 1981
DEHYDRATED BILE
K811358 · JAK
Acumedia Manufacturers, Inc.
Microbiology · 15d
Cleared May 29, 1981
AGAR, BACTERIOLOGICAL
K811359 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 15d
Cleared May 29, 1981
YEAST EXTRACT
K811360 · JSK
Acumedia Manufacturers, Inc.
Microbiology · 15d
Cleared May 29, 1981
PANCREATIC HYDROLYSATE OF HEART MUSCLE
K811361 · JSK
Acumedia Manufacturers, Inc.
Microbiology · 15d
Cleared May 29, 1981
TCBS AGAR
K811362 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 15d
Cleared May 29, 1981
KALLESTAD ANTISERA TO PHENOBARBITAL
K811367 · DLZ
Kallestad Laboratories, Inc.
Chemistry · 15d
Cleared May 29, 1981
NATAL-TEC PROGESTERONE
K811369 · JLS
Armkel, LLC
Chemistry · 15d
Cleared May 29, 1981
NATAL-TEC HPL
K811370 · JMF
Armkel, LLC
Chemistry · 15d
Cleared May 29, 1981
NATAL-TEC ESTRIOL
K811371 · CGI
Armkel, LLC
Chemistry · 15d
Cleared May 29, 1981
AMES SERA-PAK GLUCOSE REAGENT
K811392 · CGA
Miles Laboratories, Inc.
Chemistry · 11d
Cleared May 29, 1981
EARLY PREGNANCY DETECTION
K811398 · JHI
Immuchem Corp.
Chemistry · 11d