BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N

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

    PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HI-WAVE; POUR-PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    PROSPACE PEEK IMPLANT 5 7X8X22MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code MAX·June 21, 2013

    TSPACE PEEK IMPLANT 26X11X7MM

    FDA Adverse Event
    Malfunction ·AESCULAP IMPLANT SYSTEMS·Product code MAX·October 30, 2015

    ACCU-CHEK ® AVIVA

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·April 16, 2013

    GYNECARE MORCELLEX TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·June 13, 2008

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·April 18, 2011

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015