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

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    EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CLEARGLIDE PRECISION BIPOLAR DEVICE

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

    SHUTTLE STOP

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

    CLEARGLIDE EVH SMALL

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA·Product code GEI·October 2, 2009

    CLEARGLIDE EVH SMALL

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA·Product code GEI·October 14, 2009

    CLEARGLIDE EVH SMALL

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA·Product code GEI·October 14, 2009

    CLEARGLIDE EVH SMALL

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA·Product code GEI·October 14, 2009

    CLEARGLIDE EVH SMALL

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA·Product code GEI·October 16, 2009

    CLEARGLIDE EVH LONGVIEW W/SCIS

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code GEI·November 23, 2009

    CLEARGLIDE EVH SMALL

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA·Product code GEI·October 16, 2009

    CLEARGLIDE EVH SMALL W/SCISSOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code GEI·October 16, 2009

    CLEARGLIDE EVH LONGVIEW W/SCIS

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code GEI·November 9, 2009

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 2, 2013

    ASCENSION SADDLE PYROCARBON CMC

    FDA Adverse Event
    Injury ·ASCENSION ORTHOPEDICS, INC.·Product code KYI·March 18, 2011

    CONTOUR TEST STRIPS (50)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·April 15, 2008

    CLEARGLIDE EVH SMALL

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code GEI·November 24, 2009

    CLEARGLIDE EVH SMALL W/SCISSOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code GEI·November 3, 2009

    CLEARGLIDE EVH SMALL

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA·Product code GEI·October 16, 2009

    BACFIX ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020

    superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

    FDA Enforcement
    Class II ·Terminated·superDimension, Inc·July 18, 2012