BEUDAMED
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    Optimos™ Cystotome

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

    V-Strap Wrist Support

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357232567·

    PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACCU-CHEK ® INSIGHT FLEX

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code FPA·November 7, 2018

    PUMP IN STYLE ADVANCED BREASTPUMP STARTER

    FDA Adverse Event
    Injury ·MEDELA, INC.·Product code HGX·October 27, 2014

    RF MULTIGEN

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code GXD·August 16, 2011

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 12, 2013

    bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024