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

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    CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Ultraverse® 018

    FDA UDI
    Bard Peripheral Vascular, Inc.·00801741055461·Ultraverse® 018 PTA Balloon Dilatation Catheter...

    Bioplate®

    FDA UDI
    Bioplate, Inc.·M3848130840·Drill Bit - Ø1.2 mm x 6 mm

    AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RENOVIS CANNULATED SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·May 15, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    FLEXOR RAABE GUIDING SHEATH

    FDA Adverse Event
    Malfunction ·COOK, INC.·Product code DYB·August 18, 2010

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018