Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

IYN 2020-03-12

SonoVision Ultrasound Imaging System

Applicant Tissue Differentiation Intelligence, LLC

K-Number K192388

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FOZ 2020-03-12

Health Line CT Midline Catheter

Applicant Health Line International Corporation

K-Number K200263

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DIO 2020-03-12

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay

Applicant Medtest DX

K-Number K191638

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FRO 2020-03-11

AC5 Topical Gel

Applicant Arch Therapeutics, Inc.

K-Number K190129

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OQG 2020-03-11

Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System

Applicant Kyocera Medical Technologies, Inc.

K-Number K200328

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LNH 2020-03-11

MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit

Applicant Siemens Medical Solutions USA, Inc.

K-Number K192924

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PBF 2020-03-11

KLS Martin Individual Patient Solutions (IPS) Planning System

Applicant KLS-Martin L.P.

K-Number K192979

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LFC 2020-03-11

Vista Dyes

Applicant Inter-Med/Vista Dental Products

K-Number K193447

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DKZ 2020-03-11

Quidel Triage® TOX Drug Screen, 94600

Applicant Quidel Cardiovascular, Inc.

K-Number K200363

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MAI 2020-03-11

Fixone Biocomposite Anchor

Applicant Aju Pharm Co., Ltd.

K-Number K192484

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MBI 2020-03-11

Apollo Suture Anchor System

Applicant Valeris Medical

K-Number K192810

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MRN 2020-03-10

AeroNOx 2.0 Nitric Oxide Titration & Monitoring System

Applicant International Biomedical

K-Number K193481

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