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
163225–163248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 1981
HEMAQUIK
K811400 · IAF
Accra Laboratories, Inc.
Pathology · 31d
Cleared Jun 18, 1981
STREP-ID PLATE
K811422 · JSI
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 29d
Cleared Jun 18, 1981
KWIK-LAC BETA-LACTAMASE KITS
K811442
Windsor Laboratories, Inc.
Chemistry · 27d
Cleared Jun 18, 1981
MUELLER HINTON AGAR
K811471 · JTZ
Biomedia, Inc.
Toxicology · 23d
Cleared Jun 18, 1981
MUELLER HINTON AGAR, POURED INTO A PLATE
K811472 · JTZ
Biomedia, Inc.
Toxicology · 23d
Cleared Jun 18, 1981
MUELLER HINTON AGAR W/5% SHEEP BLOOD
K811473 · JTZ
Biomedia, Inc.
Toxicology · 23d
Cleared Jun 18, 1981
TRYPTIC SOY AGAR W/5% SHEEP BLOOD & EMB
K811474 · JSI
Biomedia, Inc.
Toxicology · 23d
Cleared Jun 18, 1981
TRYPTIC SOY AGAR W/5% & 10% SHEEP BLOOD
K811475 · JSG
Biomedia, Inc.
Toxicology · 23d
Cleared Jun 18, 1981
THAYER MARTIN AGAR
K811476 · JTY
Biomedia, Inc.
Toxicology · 23d
Cleared Jun 18, 1981
MACCONKEY AGAR
K811477 · JSI
Biomedia, Inc.
Toxicology · 23d
Cleared Jun 18, 1981
EMB AGAR, LEVINE
K811478 · JSI
Biomedia, Inc.
Toxicology · 23d
Cleared Jun 18, 1981
CHODOLATE AGAR, ENRICHED
K811479 · JTY
Biomedia, Inc.
Toxicology · 23d
Cleared Jun 18, 1981
COLBALT ALLOY ORTHOPAEDIC WIRE
K811500 · JDR
Osteonics Corp.
Orthopedic · 22d
Cleared Jun 18, 1981
MONOJECT STERILE M503 3CC SYRINGES
K811505 · FMF
Sherwood Medical Co.
General Hospital · 22d
Cleared Jun 18, 1981
WILKINS-CHALGREN ANAEROBE AGAR
K811513 · JSO
Oxoid U.S.A., Inc.
Toxicology · 21d
Cleared Jun 18, 1981
FLEXIGRAM AUTO LOADER SYSTEM
K811525 · JJG
Electro-Nucleonics Laboratories, Inc.
Chemistry · 20d
Cleared Jun 18, 1981
DIRECT TESTOSTERONE RIA
K811536 · CDZ
Immuchem Corp.
Chemistry · 17d
Cleared Jun 18, 1981
MODEL SP 5507 5-LUMEN THERMODILUTION CAT
K811537 · KRB
Gould, Inc.
Cardiovascular · 17d
Cleared Jun 18, 1981
MGN CONNECTING TUBE
K811541 · BYY
Mgn Medical Manufacturing, Inc.
General Hospital · 17d
Cleared Jun 18, 1981
MGN SUCTION CATHETER
K811542 · BSY
Mgn Medical Manufacturing, Inc.
Anesthesiology · 17d
Cleared Jun 18, 1981
MATELAS COQUILLE LATTREDE TASSIGNY
K811547 · FPP
Firn-France
General Hospital · 17d
Cleared Jun 18, 1981
TIMETER PRODUCED SCHRADER OXYGEN ADAPTOR
K811549 · BYX
Timeter Instrument Corp.
Anesthesiology · 16d
Cleared Jun 18, 1981
TIMETER PRODUCED CHEMETRON (NCG) AIR
K811550 · BYX
Timeter Instrument Corp.
Anesthesiology · 16d
Cleared Jun 18, 1981
TIMETER PRODUCED OHIO OXYGEN ADAPTOR
K811551 · BYX
Timeter Instrument Corp.
Anesthesiology · 16d