BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Neurology

    AGXO

    FDA UDI
    Oticon A/S·05707131258090·H150, MINIBTE 312 WL 85 CNB AGXO

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857560666·Trial With Stop Size 12x14x9 mm, 4 Degrees

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·July 11, 2005

    VERSATREK

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SYNOVIS COLLAGEN MATRIX (TBD)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·October 1, 2014

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·May 1, 2013

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·June 13, 2011

    Reference Electrodes for ABL 700/800 Blood Gas Analyzers. Electrode Part Number: 945-603, distributed one (1) electrode per box.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CHL·September 19, 2005

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023