BEUDAMED
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    OSTEONICS UNIX UNICOMPARTMENTAL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LOOPTAPE

    FDA UDI
    RIVERPOINT MEDICAL, LLC·00840277410313·Suture

    PROFYLE

    FDA UDI
    Stryker GmbH·34546540244872·BONE SCREWS, CROSS-FIT, SELF-TAPPING

    Forceps

    FDA UDI
    KOROS U.S.A., INC.·10840199539526·Mixter Forceps 28cm 11"

    OSMONICS SOLUTION DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VC III

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CAPSUREFIX

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010

    DIMENSION XPAND PLUS WITH HM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·July 9, 2014

    SM204 M-SERIES W/BIG WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·December 27, 2012

    Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·February 12, 2020

    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 16, 2018