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

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    PERMANENT MYOCARDIAL LEADS MP SERIES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    BMLS16-1

    FDA 510(k)
    FDA Class 2 ·Neurology

    TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SHELL WITH CLUSTER HOLES POROUS

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·December 17, 2018

    FEMORAL STEM PRESS-FIT COLLARLESS

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·December 17, 2018

    DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·June 13, 2014

    THORACIC TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GEA·October 18, 2010

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·December 13, 2012

    V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·October 19, 2016