BEUDAMED
    12 results · 25ms · Sources: EU EUDAMED, US FDA

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    ORTHO IMPLANT AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Dental

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756119481·ELASTIC BANDAGE

    icotec Lumbar Cage PLIF 8° / 25 mm x 09 mm

    FDA UDI
    icotec AG·07640140438269·icotec Lumbar Cage PLIF 8° / 25 mm x 09 mm

    icotec Lumbar Cage PLIF 8° / 25 mm x 09 mm

    FDA UDI
    icotec AG·07640164848396·icotec Lumbar Cage PLIF 8° / 25 mm x 09 mm

    EOS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SAXON RIBBED CONDOMS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·January 11, 2019

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·February 26, 2013

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 9, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 6, 2014

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·November 13, 2018

    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