BEUDAMED
    10 results · 24ms · Sources: EU EUDAMED, US FDA

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    PUREtrace™

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    OrthoMedFlex, LLC

    FDA UDI
    ORTHOMEDFLEX LLC·M7161121532620·

    QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 1, 2013

    LINEAR 7.5 FR. 34CC IAB

    FDA Adverse Event
    Death ·DATASCOPE CORP.·Product code DSP·July 1, 2011

    REVEAL XT

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code DSI·June 8, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORP.·Product code LZG·September 8, 2008

    ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023