BEUDAMED
    10 results · 24ms · Sources: EU EUDAMED, US FDA

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    Talee, Talee PostOP

    FDA 510(k)
    FDA Class 2 ·Neurology

    EBI OMEGA21 SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADVIA CHEMISTRY GLUH_3 REAGENTS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BARRIGEL INJECTABLE GEL

    FDA Adverse Event
    Malfunction ·PALETTE LIFE SCIENCES·Product code OVB·June 24, 2024

    DOW CORNING

    FDA Adverse Event
    Injury ·Product code FTR·November 3, 2008

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·August 23, 2011

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·July 8, 2013

    Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO

    FDA Enforcement
    Class I ·Ongoing·Abbott Vascular·May 25, 2022

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 2015

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024