BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIGHT-CURED PERIODONTAL DRESSING

    FDA 510(k)
    FDA Class 2 ·Dental

    POWERCUT SURGICAL SYSTEM, BLADES, AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HIRES 90K ADVANGAGE IMPLANT

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS LLC·Product code MCM·June 19, 2014

    CONCERTO II CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code NIK·February 15, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020