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

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    FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ELECTRO

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 18, 2011

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 22, 2013

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014