BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    MICRO SURGICAL INSTRUMENT SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    LARGE AO COUPLING ASNIS III HALL FITTING

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 25, 2012

    WIDEX HEARING AID MODEL C1

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    BITEK(TM) BLOOD CULTURE SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 19, 2014

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·October 25, 2010

    A4545 (5) PACK, THR-050-4F 5/BOX

    FDA Adverse Event
    Injury ·APPLIED MEDICAL·Product code DXE·December 18, 2012

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024