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

PMN 2017-03-14

FilmArray Warrior Control Panel M290

Applicant Maine Molecular Quality Controls, Inc.

K-Number K163522

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EMA 2017-03-14

TotalC-Ram

Applicant Itena Clinical

K-Number K162960

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JWY 2017-03-14

Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL

Applicant Liofilchem s.r.l.

K-Number K163517

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KLA 2017-03-14

THD ANOPRESS

Applicant Thd Spa

K-Number K161785

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EBI 2017-03-13

mollosil plus

Applicant Detax GmbH & Co. KG

K-Number K162654

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GCJ 2017-03-13

FUJIFILM Surgical System

Applicant Fujifilm New Development U.S.A., Inc.

K-Number K162836

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HRS 2017-03-13

ORTHOLOC® 3Di Small Bones Plating

Applicant Wrightmedicaltechnologyinc

K-Number K163039

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GCJ 2017-03-13

NOVATECH TALCAIR

Applicant Novatech SA

K-Number K170030

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LON 2017-03-13

VITEK 2 AST-GN Gentamicin (<=1 >=16 µg/mL)

Applicant bioMerieux, Inc.

K-Number K163563

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MAI 2017-03-13

ZipE Knotless Tissue Repair and Attachment Devices

Applicant Ziptek, LLC

K-Number K162429

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OLO 2017-03-13

Navigated Instrument System

Applicant Orthofix, Inc.

K-Number K162921

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GEI 2017-03-13

Thermi Injectable RF Electrodes

Applicant Thermi

K-Number K170116

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