BEUDAMED
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    SUPER VELOCE

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

    LGN PS HIGH FLEX XLPE SZ 1-2 13MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·April 24, 2019

    GEN II CEMENTED TIBIAL B/PLATE SZ 2 LEFT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·April 24, 2019

    VASSEN COLOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    13.5CM ANGLE ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·November 10, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 9, 2011

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTN·July 22, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    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