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
145009–145032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 1986
BIOTIS NUTRIENT GELATIN
K860396 · JTO
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS TSA
K860397 · JSG
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS POTATO DEXTROSE AGAR
K860398 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS TODD HEWITT BROTH
K860399 · JSG
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS TRYPTIC SOY AGAR SLANTS
K860401 · JSG
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS BISMUTH SULFITE AGAR
K860402 · JSI
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS TSA WITH 5% RABBIT BLOOD
K860403 · JSG
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS MIDDLEBROOK 7H10 AGAR SLANT
K860404 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS TSB WITH 6.5% NACL
K860405 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS MIDDLEBROOK 7H9 BROTH
K860406 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS ANAEROBIC CNA
K860407 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS NUTRIENT AGAR
K860408 · JSG
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS COLUMBIA SHEEP BLOOD AGAR
K860409 · JSG
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS COOKED MEAT
K860410 · KZI
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS BHI AGAR
K860411 · JSG
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS SIM MEDIUM
K860412 · JSE
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS TSI
K860413 · JSE
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS ORNITHINE INDOLE MOTILITY MEDIA
K860414 · JSE
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS SIMMON CITRATE AGAR
K860415 · JSE
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS REGAN-LOWE
K860416 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
SICKLE CELL REAGENT SET
K860420 · GHM
Sterling Diagnostics, Inc.
Hematology · 20d
Cleared Feb 24, 1986
MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.
K860466 · DXY
Cook Pacemaker Corp.
Cardiovascular · 18d
Cleared Feb 24, 1986
EUROTAN BY AYK
K860489 · FTC
Eurotan Intl.
General & Plastic Surgery · 14d
Cleared Feb 21, 1986
COMBISCOPE
K852655 · KNG
Instrument Technology, Inc.
Obstetrics & Gynecology · 242d