BEUDAMED
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    iLoop Interventional Coil 0.55T

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    SYNTHES (U.S.A.) LP·10886982165688·3.5MM CLAVICLE HOOK PLATE 8 HOLES LEFT-18MM HOO...

    SPIRALOK ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Lung Density Analysis

    FDA 510(k)
    FDA Class 2 ·Radiology

    90 DEG LOCKING CANNULATED INFANT BLADE 35MM X 5MM X 3 HOLE

    FDA Adverse Event
    Malfunction ·ORTHOPEDIATRICS·Product code HRS·October 24, 2025

    PUMP MMT-522NAL PRDGM INS V2.2 CL EN

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

    RESTORE ULTRA

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

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·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