BEUDAMED
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    VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin

    FDA 510(k)
    FDA Class 2 ·Microbiology

    VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LINK Embrace Shoulder System- Anatomical Configuration

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD¿ SYRINGE LL EUROGRAPHICS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 3, 2019

    PROFEMUR(R) Z STEM PLASMA SPRAYED

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code LPH·October 30, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 17, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019