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

NGX 2019-02-12

WiEMSpro

Applicant Medical Cables S.L.

K-Number K181955

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NFJ 2019-02-12

KOWA VK-2s

Applicant Kowa Co. Ltd. Chofu

K-Number K190056

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LTT 2019-02-12

MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL)

Applicant Beckman Coulter, Inc.

K-Number K183127

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HQD 2019-02-12

Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens

Applicant Bausch & Lomb, Incorporated

K-Number K183167

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MUH 2019-02-12

Cruxcan (CRX-1000)

Applicant Cruxell Corp.

K-Number K183637

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JJE 2019-02-12

Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode

Applicant Horiba, Ltd.

K-Number K183375

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MDB 2019-02-11

BacT/ALERT FA Plus; BacT/ALERT PF Plus

Applicant bioMerieux, Inc.

K-Number K183166

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KWQ 2019-02-11

Athena II Cervical Plate System

Applicant Medyssey USA, Inc.

K-Number K183409

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HSX 2019-02-11

Journey II Unicompartmental Knee System

Applicant Smith & Nephew, Inc.

K-Number K190085

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GDW 2019-02-11

easyPPHTM Hemorrhoidal Stapler for Single Use

Applicant Ezisurg Medical Co., Ltd.

K-Number K183477

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FGE 2019-02-11

HANAROSTENT FASTTM Biliary (NNN)

Applicant M.I.Tech Co., Ltd.

K-Number K183396

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JDI 2019-02-11

Cemented TSI Hip Stem

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K181340

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