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
155689–155712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1983
T3-RIA SINGLE REAGENT
K832469 · CDP
Fairlake Laboratories
Chemistry · 49d
Cleared Sep 12, 1983
ADJUSTABLE PHARYNGEAL AIRWAY/BERMAN III
K832471 · CAE
Inmed Corp.
Anesthesiology · 48d
Cleared Sep 12, 1983
TRUST RPR CARD TEST #65144
K832479 · GMQ
Emd Chemicals, Inc.
Hematology · 48d
Cleared Sep 12, 1983
TRUST RPR TITRATION CARD TEST #65145
K832480 · GMQ
Emd Chemicals, Inc.
Hematology · 48d
Cleared Sep 12, 1983
CONVEEN DRIP COLLECTOR/NET PANTS
K832489 · EYQ
Telcam Medical Devices, Inc.
Gastroenterology & Urology · 47d
Cleared Sep 12, 1983
QUINIDINE FLUORESCENT IMMUNOASSAY
K832493 · LBZ
American Diagnostic Corp.
Chemistry · 47d
Cleared Sep 12, 1983
BIO SURE STAIN
K832496 · IDA
Helena Laboratories
Chemistry · 47d
Cleared Sep 12, 1983
PHASE II TSH KIT
K832499 · JLW
Medical & Scientific Designs, Inc.
Chemistry · 47d
Cleared Sep 12, 1983
ELECTRON BEAM OPTION FOR CLINAC 15 MEV
K832502 · IYE
Varian Assoc., Inc.
Radiology · 49d
Cleared Sep 12, 1983
CLINAC 1800
K832503 · IYE
Varian Assoc., Inc.
Radiology · 49d
Cleared Sep 12, 1983
CRONEX LO-DOSE MAMMOGRAPHY
K832504 · IWZ
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 53d
Cleared Sep 12, 1983
IMAGE PROCESSING SYS A3
K832505 · IYX
Metronic, Inc.
Radiology · 47d
Cleared Sep 12, 1983
PREGNA-TEC
K832527 · JHJ
Medilab Corp.
Chemistry · 45d
Cleared Sep 12, 1983
CONVEEN LEG BAG W/TUBE-DRAINAGE BAG
K832537 · KNX
Telcam Medical Devices, Inc.
Gastroenterology & Urology · 47d
Cleared Sep 12, 1983
NEONATAL LUMBAR PUNCTURE TRAY
K832556 · FMI
American Pharmaseal Div. Ahsc
General Hospital · 42d
Cleared Sep 12, 1983
FERTITELL DIRECT PREGNANCY TEST #1100
K832557 · JHJ
Stanbio Laboratory
Chemistry · 42d
Cleared Sep 12, 1983
SERUM HCG ASSAY
K832562 · JHI
Monoclonal Antibodies, Inc.
Chemistry · 41d
Cleared Sep 12, 1983
DISCO SUNGLASSES/HEADBAND SUNGLASSES
K832564 · HQY
E-Tay Industrial Co. , Ltd.
Ophthalmic · 41d
Cleared Sep 12, 1983
ACETAMINOPHEN(PARACETAMOL
K832567 · LDP
Bio-Analytics Laboratories, Inc.
Chemistry · 41d
Cleared Sep 12, 1983
INDOLE NITRATE MEDIUM
K832568 · JSE
Acumedia Manufacturers, Inc.
Microbiology · 41d
Cleared Sep 12, 1983
INFUSION BROTH
K832569 · JSC
Acumedia Manufacturers, Inc.
Microbiology · 41d
Cleared Sep 12, 1983
EXTRACT BROTH
K832570 · JSC
Acumedia Manufacturers, Inc.
Microbiology · 41d
Cleared Sep 12, 1983
BILE ESCULIN AZIDE AGAR
K832571 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 41d
Cleared Sep 12, 1983
BILE ESCULIN AGAR
K832572 · JSI
Acumedia Manufacturers, Inc.
Microbiology · 41d