BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    SCANLAN COLORMARK SKIN MARKER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Precept

    FDA UDI
    Nuvasive, Inc.·00887517370440·PRECEPT Rod, 85mm

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377020840·RELINE-C Ti Rod, 3.5x85mm Straight

    LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WestTec Procedure Facemask;WestTec Surgical Facemask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    JUVEDERM ULTRA XC 1 ML ROW

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LMH·May 16, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·November 20, 2012

    CLAVICLE PLATING SYSTEM

    FDA Adverse Event
    Injury ·ORTHOHELIX SURGICAL DESIGN·Product code HRS·September 15, 2010

    Assurity MRI Model Numbers: PM1272, PM2272 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