BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    HAPEX MALLEABLE PORP

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    TriFit TS Blade Stem

    FDA UDI
    CORIN LTD·05055343866795·Double Offset Broach Handle - Right

    OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG

    FDA 510(k)
    FDA Unclassified ·Unknown

    MAGEC 2 Spinal Bracing and Distraction System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROULTRA ENDO TIPS

    FDA Adverse Event
    Malfunction ·DENTSPLY MAILLEFER·Product code ELC·June 8, 2006

    LD304 MATERNITY BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code HDD·May 29, 2015

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 13, 2014

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    LAND AMERICA HEALTH & FITNESS·Product code FSA·February 8, 2013

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code LFR·January 6, 2011

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 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