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

HTY 2019-07-23

Hammertoe Truss System (HTS)

Applicant 4Web, Inc.

K-Number K190926

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QGG 2019-07-22

BAROnova Access Sheath Kit

Applicant Baronova, Inc.

K-Number K191078

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HEB 2019-07-22

CottonDay Tampon

Applicant Taebong Co., Ltd.

K-Number K182817

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LZO 2019-07-22

Revival Modular Hip Stem

Applicant Corin U.S.A. Limited

K-Number K191374

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LYZ 2019-07-22

Powder-Free Vinyl Patient Examination Gloves, Yellow Color

Applicant Anhui Intco Medical Products Co., Ltd.

K-Number K191092

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DXN 2019-07-22

Digital Automatic Blood Pressure Monitor MD36 Series

Applicant Grandway Technology (Shenzhen) Limited

K-Number K191593

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LZO 2019-07-22

Corin Optimized Position System Functional Hip Analysis (OPS FHA)

Applicant Corin USA

K-Number K190834

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JOW 2019-07-22

Plexus SCD110 Sequential Compression Device Sleeve

Applicant Midway Medical, LLC

K-Number K190975

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DQX 2019-07-22

Roadrunner PC Wire Guide, Olcott Torque Device

Applicant Cook Incorporated

K-Number K182985

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DQY 2019-07-20

CerusEndo Microcatheter

Applicant Cerus Endovascular, Inc.

K-Number K182487

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DQK 2019-07-20

CARTO 3 EP Navigation System, Version 7.1 and Accessories

Applicant Biosense Webster, Inc.

K-Number K191660

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JGS 2019-07-19

Stat Profile Prime ES Comp Plus Analyzer System

Applicant Nova Biomedical Corporation

K-Number K191365

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