FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
128905–128928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1989
ALANINE AMINOTRANSFERASE (ALT)
K896001 · CKA
American Monitor Corp.
Chemistry · 31d
Cleared Nov 13, 1989
NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.
K896321 · BSY
Superior Healthcare Group, Inc.
Anesthesiology · 12d
Cleared Nov 09, 1989
RAPIDEC STAPH
K891004 · LQL
Dms Products, Inc.
Microbiology · 254d
Cleared Nov 09, 1989
PROMONTORY STIMULATING ELECTRODE
K895081 · GXY
Cadwell Laboratories, Inc.
Neurology · 87d
Cleared Nov 09, 1989
CROSS CANCELLOUS BONE SCREW
K896044 · HWC
Buckman Co., Inc.
Orthopedic · 23d
Cleared Nov 09, 1989
FIBRINOGEN ASSAY KIT
K896052 · KQJ
Medical Diagnostic Technologies, Inc.
Hematology · 22d
Cleared Nov 09, 1989
ALKALINE PHOSPHATASE, LEUKOCYTE, KIT
K896092 · GHD
Sigma Chemical Co.
Hematology · 21d
Cleared Nov 09, 1989
PARA TECH FOR TECHNICON H-1
K896154 · JCN
Streck Laboratories, Inc.
Hematology · 16d
Cleared Nov 08, 1989
BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900
K892443 · CAC
Gish Biomedical, Inc.
Anesthesiology · 212d
Cleared Nov 08, 1989
NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS
K892856 · KRI
Acacia Laboratories, Inc.
Cardiovascular · 204d
Cleared Nov 08, 1989
LATEX EXAMINATION GLOVES
K893350 · LYY
Pan Africa Exports , Ltd.
General Hospital · 201d
Cleared Nov 08, 1989
QUANTAI UG REAGENT STRIP
K893661 · CGA
Quantai Biotronics, Inc.
Chemistry · 177d
Cleared Nov 08, 1989
DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST
K894106 · FIP
Cd Medical, Inc.
Gastroenterology & Urology · 152d
Cleared Nov 08, 1989
CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS
K894715 · CGS
Catachem, Inc.
Chemistry · 106d
Cleared Nov 08, 1989
ULTRACOMPACT
K894968 · EXY
Eutectic Electronics, Inc.
Gastroenterology & Urology · 93d
Cleared Nov 08, 1989
DAVOL ARTHROSCOPY CANNULA
K894990 · HRX
Davol, Inc.
Orthopedic · 92d
Cleared Nov 08, 1989
COMA COCAINE METABOLITE ASSAY (EIA)
K895043 · DIO
Serex, Inc.
Toxicology · 91d
Cleared Nov 08, 1989
NF-1 MINDPEACE
K895175 · QJQ
Neurofitness
Neurology · 90d
Cleared Nov 08, 1989
FIAGEN T3 UPTAKE CATALOGUE #101-402
K895186 · KHQ
Cyberfluor, Inc.
Chemistry · 89d
Cleared Nov 08, 1989
THE ON-GARD RECAPPER
K895220 · FMF
On-Gard Systems, Inc.
General Hospital · 84d
Cleared Nov 08, 1989
LASERMATIC COMBOLASER MODEL 5050
K895279 · GEX
Lasermatic OY
General & Plastic Surgery · 76d
Cleared Nov 08, 1989
TRANSDUCER PROTECTOR
K895281 · FIB
Filtertek, Inc.
Gastroenterology & Urology · 76d
Cleared Nov 08, 1989
HDL SINGLES
K895381 · LBR
Trace America, Inc.
Chemistry · 71d
Cleared Nov 08, 1989
LATEX EXAMINATION GLOVES
K895552 · LYY
Jung Hua Co.
General Hospital · 56d