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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    ARTHREX SMALL FRAGMENT PLATES AND SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STACKED ABR FOR NAVIGATOR PRO

    FDA 510(k)
    FDA Class 2 ·Neurology

    NEUROLINE, SUBDERMAL NEEDLE ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    VERITAS COLLAGEN MATRIX

    FDA Adverse Event
    Injury ·SYNOVIS SURGICAL INNOVATIONS·Product code FTM·April 8, 2013

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011

    PUPPY DOG ELECTRODE

    FDA Adverse Event
    Injury ·TYCO HEALTHCARE GROUP LP·Product code DRX·May 9, 2008

    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

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018