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

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    ProMIS™ Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Surgical Face Mask, Surgical Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LONG NAIL KIT R1.5, LEFT 10X260MM X 125

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 16, 2010

    ALARIS INFUSION SYSTEM

    FDA Adverse Event
    Injury ·CARDINAL HEALTH ALARIS PRODUCTS·Product code FRN·November 12, 2008

    PINNACLE MTL INS NEUT36IDX56OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·September 1, 2011

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    FDA Adverse Event
    Injury ·COOK, INC.·Product code MIH·July 12, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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