Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
156529–156552 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 12, 1983
ANDROSTENEDIONE TEST SET 125I
K832452 · CIZ
Wien Laboratories, Inc.
Chemistry · 49d
Cleared Sep 12, 1983
A-GENT PHENOBARBITAL
K832457 · DLZ
Abbott Laboratories
Toxicology · 48d
Cleared Sep 12, 1983
TRIGLYCERIDE REAGENT-TRINDER-GPO
K832460 · JGY
Seppim, Inc.
Chemistry · 48d
Cleared Sep 12, 1983
AUTOPAK NEONATAL TSH RIA KIT
K832462 · JLW
Micromedic Systems
Chemistry · 48d
Cleared Sep 12, 1983
RAICHEM ALKALINE PHOSPHATASE REAGENT
K832463 · CJE
Reagents Applications, Inc.
Chemistry · 48d
Cleared Sep 12, 1983
T4-RIA SINGLE REAGENT
K832468 · CDX
Fairlake Laboratories
Chemistry · 49d
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