BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    EBI DISTAL RADIUS PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LAP DISC HAND ACCESS DEVICE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.·Product code GCJ·July 1, 2005

    SKYLIGHT IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDICON TITANIUM YASARGIL ANEURYSM CLIPS

    FDA 510(k)
    FDA Class 2 ·Neurology

    LIGACLIP ENDOSCOPIC ROTATING CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 8, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·March 23, 2011

    MEDTRONIC MINIMED

    FDA Adverse Event
    Other ·MEDTRONIC·Product code LZG·May 13, 2008

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare·February 5, 2014

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Recall
    Terminated ·Philips Healthcare·Product code NCX·January 13, 2014

    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

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016