BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    HANDI PORCH ELEVATOR & LIBERTY WHEELCHAIR LIFT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867050709·LO-PRO SCRW,TI,3.5MMX 44MM

    TROPAZONE CR

    FDA 510(k)
    FDA Unclassified ·Unknown

    IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS.

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNKNOWN

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·January 2, 2013

    SPACEMAKER BLUNT TIP TROCAR 12MM

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY USSC·Product code GCJ·February 14, 2014

    OT BASIC METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·November 8, 2010

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017