BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    RENAMELIZE POLISHING PASTE

    FDA 510(k)
    FDA Class 1 ·Dental

    VIPER PRIME™ additions to the VIPER® System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCIENT'X SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 20, 2014

    ATTAIN STARFIX

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 9, 2010

    PRECISE (TM) BIPOLAR FORCEPS

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·December 10, 2012

    Lithotomy Pack, Kit number AMS2333 and AMS2333(A convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021