Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

LHI 2017-10-03

Arisure Closed Vial Adapter

Applicant Yukon Medical

K-Number K172884

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LPH 2017-10-03

Smith & Nephew, Inc. ANTHOLOGY AFIT Hip Stem

Applicant Smith & Nephew, Inc.

K-Number K172684

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JTN 2017-10-03

HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)

Applicant Hardy Diagnostics

K-Number K172621

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GAT 2017-10-03

Force Fiber Fusion Suture

Applicant Teleflex Medical Incorporated

K-Number K172016

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PLP 2017-10-03

Ablatherm Fusion

Applicant Edap Technomed, Inc.

K-Number K172285

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KWS 2017-10-02

ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)

Applicant Stryker Trauma AG

K-Number K172210

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HGX 2017-10-02

Yooeehouse Breast Pump

Applicant Nantong Poly Technology Co., Ltd.

K-Number K163183

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DXH 2017-10-02

ECG Check - Universal, ECG Check - Universal Plus

Applicant Cardiac Designs, Inc.

K-Number K170506

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GEI 2017-10-02

iSurg

Applicant Jaco, LLC Dba Macan Manufacturing and Bna Burz North America

K-Number K170054

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NKG 2017-10-02

BRIDALVEIL Occipital Cervical Thoracic System

Applicant Astura Medical

K-Number K171250

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EBI 2017-10-02

Nobilplast Denture Resin

Applicant Cmp Industries, LLC

K-Number K170375

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EBF 2017-10-02

Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl

Applicant Swissmeditec GmbH

K-Number K170873

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