BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DZIDRA GLASS FOR USE IN DENTISTRY

    FDA 510(k)

    PYLORISET

    FDA 510(k)
    FDA Class 1 ·Microbiology

    REVO MRI SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWP·February 15, 2013

    CARDIOVASCULAR PROCEDURE KIT

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code OEZ·December 23, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 29, 2014

    InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.

    FDA Recall
    Terminated ·Intervascular S.A.S. Zone Industrielle Athelia I La Ciotat Cedex France·Product code DSY·December 9, 2009

    Set-Up Pack, part number PSS1305(C

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017