BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    KODAK X-OMAT FIXER MANAGER

    FDA 510(k)
    FDA Class 2 ·Radiology

    PHILIPS M5066A AND M5068A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    CURLIN 6000

    FDA Adverse Event
    Malfunction ·MOOG·Product code FRN·November 1, 2010

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·January 17, 2013

    CPS DUO

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code DQY·July 8, 2014