BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    CrossRoads Modular Tray System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MaXcess

    FDA UDI
    Nuvasive, Inc.·00887517197139·MaXcess 4 Blade, 50mm Left

    Pomee

    FDA UDI
    POMEE CORPORATION·G15772410500·Mosquito forceps 5" straight

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690121251·Femoral Augment Posterior, Size 1+, 5mm

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690121879·Femoral Posterior Augment Trial, Size 1+, 5mm

    ENSITE VELOCITY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIGORA OPTIME (OR DIGORA ONTIME)

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 19, 2024

    PUMP MMT-712WWP PRDGM INSULIN PL EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·November 21, 2008

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 17, 2011

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 18, 2013

    VYSIS CLL FISH PROBE KIT

    FDA Adverse Event
    Malfunction ·ABBOTT MOLECULAR, INC.·Product code OVQ·August 26, 2021

    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