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
149377–149400 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 1985
NEBULIZER TREATMENT KIT
K850320
Dhd Medical Products Div. Diemolding...
Cardiovascular · 36d
Cleared Mar 05, 1985
WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D
K850359 · LDM
Millipore Corp.
Chemistry · 34d
Cleared Mar 05, 1985
GLUCOSE - TRINDER- REAGENT
K850364 · CGA
Sigma Chemical Co.
Chemistry · 34d
Cleared Mar 05, 1985
DESERET EPIDURAL CATHETER
K850439 · BSO
Parke-Davis Co.
Anesthesiology · 28d
Cleared Mar 05, 1985
DU PONT DIGOXIN ASSAY CALIBRATOR
K850457 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 27d
Cleared Mar 05, 1985
DUPONT DIGOXIN ASSAY REAGENTS
K850458 · KXT
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 27d
Cleared Mar 05, 1985
OVU STICK SELF-TEST -MODIFICATION
K850480 · CEP
Monoclonal Antibodies, Inc.
Chemistry · 34d
Cleared Mar 05, 1985
SPQ TEST SYSTEM FOR HAPTOGLOBIN
K850584 · DAD
Applications Lab
Immunology · 20d
Cleared Mar 05, 1985
SPQ TEST SYSTEM FOR COMPLEMENT C3
K850588 · CZW
Applications Lab
Immunology · 20d
Cleared Mar 05, 1985
SPQ TEST SYSTEM FOR TRANSFERRIN
K850589 · DDG
Applications Lab
Immunology · 20d
Cleared Mar 05, 1985
SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN
K850603 · DEB
Applications Lab
Immunology · 18d
Cleared Mar 05, 1985
ENZYMATIC ALPHA-AMYLASE REAGENT KIT
K850639 · CIW
Bio-Analytics Laboratories, Inc.
Chemistry · 14d
Cleared Mar 04, 1985
HI-LO TEMP THERMOCOUPLE TO THERMISTER ADAPTOR
K844201 · FLL
Mallinckrodt Critical Care
General Hospital · 125d
Cleared Mar 04, 1985
FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES
K844346 · JHJ
Fisher Diagnostics
Chemistry · 115d
Cleared Mar 04, 1985
TROGIDE
K844696 · BTR
Carmel Medical Devices
Anesthesiology · 91d
Cleared Mar 04, 1985
CHLAMYDIAL TRANSPORT MEDIA
K850124 · JSM
Hillcrest Biologicals
Microbiology · 49d
Cleared Mar 04, 1985
TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT
K850159 · JHI
Hybritech, Inc.
Chemistry · 48d
Cleared Mar 04, 1985
DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU
K850191 · HPT
Bio-Rad
Ophthalmic · 45d
Cleared Mar 04, 1985
SUCTION REGULATOR 7700 SERIES
K850200 · KDP
Boehringer Laboratories
General Hospital · 45d
Cleared Mar 04, 1985
LEECO CONCEP-7-BHCG LEIAD II
K850201 · JHI
Leeco Diagnostics, Inc.
Chemistry · 45d
Cleared Mar 04, 1985
TERUMO SENSIBEAD EIA TSH KIT
K850376 · JLW
Terumo Medical Corp.
Chemistry · 32d
Cleared Mar 04, 1985
EMEM W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN
K850510 · KIT
Mediatech, Inc.
Microbiology · 24d
Cleared Mar 01, 1985
PHONOANGIOGRAPHIC SPECTRAL ANALYZER
K840169 · DPW
Biotronics Instruments
Cardiovascular · 410d
Cleared Mar 01, 1985
DISPOSABLE ECG ELECTRODE
K841944 · DRX
Bristol Medical Electronics Corp.
Cardiovascular · 294d