BEUDAMED
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    Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging

    FDA 510(k)
    FDA Class 2 ·Radiology

    LCP

    FDA UDI
    Synthes GmbH·10886982166012·3.5MM LCP T-PLATE 4H HEAD/ 6H SHAFT/78MM-RIGHT ...

    MICROCYN WOUND CARE DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)

    FDA 510(k)
    FDA Class 2 ·Hematology

    ALARIS SYSTEM

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

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code MTA·November 20, 2008

    PICC KIT 2-LUMEN: 5 FR X 19-5/8 (50 CM)

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code LJS·August 17, 2011

    DEXTRUS 4135

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·July 22, 2013

    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