BEUDAMED
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    s-Clean ScanHealing Abutment

    FDA 510(k)
    FDA Class 2 ·Dental

    NA

    FDA UDI
    SYNTHES (U.S.A.) LP·10886982165626·3.5MM CLAVICLE HOOK PLATE 6 HOLES LEFT-15MM HOO...

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517083095·

    LINSCAN 808, LINSCAN 980

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

    SMARTWAVE MS 2000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INJ. OPTIV DH, W/OEM

    FDA Adverse Event
    Malfunction ·LIEBEL-FLARSHEIM·Product code IZQ·August 11, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 29, 2025

    ALARIS SYSTEM

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

    OPTIVANTAGE DH

    FDA Adverse Event
    Malfunction ·LIEBEL-FLARSHEIM·Product code DXT·October 6, 2017

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·November 21, 2008

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·August 16, 2011

    SOFLEX THREE-PIECE FOLDABLE LENS

    FDA Adverse Event
    Injury ·BAUSCH & LOMB, INC.·Product code HQL·April 12, 2006

    EQUINOXE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·December 8, 2023

    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