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
163705–163728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1981
GC AGAR
K811053 · JTY
Acumedia Manufacturers, Inc.
Microbiology · 13d
Cleared Apr 29, 1981
BIGGY AGAR
K811054 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 13d
Cleared Apr 29, 1981
BRAIN HEART INFUSION
K811056 · JSC
Acumedia Manufacturers, Inc.
Microbiology · 13d
Cleared Apr 29, 1981
BRILLIANT GREEN BILE BROTH 2%
K811057 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 13d
Cleared Apr 29, 1981
BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M
K811067 · KZT
Marion Laboratories, Inc.
Microbiology · 12d
Cleared Apr 29, 1981
125 I-T4 RIA TEST KIT
K811070 · CDX
Intl. Immunoassay Laboratories, Inc.
Chemistry · 9d
Cleared Apr 29, 1981
A QUAPAK
K811073 · BTT
Respiratory Care, Inc.
Anesthesiology · 9d
Cleared Apr 29, 1981
GLUCOSE REAGENT-ENZYMATIC-COLOR 500
K811074 · CGA
Reagents Applications, Inc.
Chemistry · 9d
Cleared Apr 29, 1981
MEDULLARY CANAL SCRAPERS
K811081 · HTO
The Anspach Effort, Inc.
Orthopedic · 8d
Cleared Apr 24, 1981
MICROWAVE OVEN 2M9810
K803104
Travenol Laboratories, S.A.
General Hospital · 136d
Cleared Apr 23, 1981
SR-IV PROGRAMMED SUBJECTIVE REFRACTOR
K802183 · HKO
American Optical Corp.
Ophthalmic · 226d
Cleared Apr 23, 1981
OPHTHALMO ECHOGRAPH MODEL ZD255G
K802635 · IYO
Jedmed Instrument Co.
Radiology · 183d
Cleared Apr 23, 1981
AUTO REFRACTOMETER NR-1000
K802958 · HKO
Nippon Kogaku, Inc.
Chemistry · 154d
Cleared Apr 23, 1981
INTRAVASCULAR CATHETER
K803238 · FOZ
G.D. Searle and Co.
General Hospital · 121d
Cleared Apr 23, 1981
MULTIMICRO SURGICAL CAUTERY
K810012 · HQP
Medical Products Development, Inc.
Ophthalmic · 108d
Cleared Apr 23, 1981
MULTIPERFECTEMP CAUTERY
K810013 · HQP
Medical Products Development, Inc.
Ophthalmic · 108d
Cleared Apr 23, 1981
REPLACABLE BATTERY PERFECTEMP CAUTERY
K810016 · HQP
Medical Products Development, Inc.
Ophthalmic · 108d
Cleared Apr 23, 1981
B.J.'S UVA SUN TAN BED W/SUN ROOF
K810476 · FTC
B.J. Ent.
Radiology · 59d
Cleared Apr 23, 1981
CARDIOPULMONARY BYPASS OXYGENATOR
K810505 · DTZ
Cobe Laboratories, Inc.
Cardiovascular · 58d
Cleared Apr 23, 1981
DISPOSABLE 2-STAGE CANNULA
K810515 · DWF
Texas Medical Products, Inc.
Cardiovascular · 57d
Cleared Apr 23, 1981
CHEM-DIALYTE CONCENTRATES
K810527 · KPO
Luchem Pharmaceuticals, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 23, 1981
DIRECT WRITING VECTORCARDIOGRAPH
K810529 · DYC
Elmed, Inc.
Cardiovascular · 56d
Cleared Apr 23, 1981
DISPOSABLE STOPCOCK
K810532 · DTZ
Texas Medical Products, Inc.
Cardiovascular · 56d
Cleared Apr 23, 1981
PACEMAKER LEAD ADAPTER
K810551 · DTD
Pacesetter Systems
Cardiovascular · 52d