BEUDAMED
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    Hair Regrowth Cap (Model: T-119-HRC)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Medical X-ray Green / MXG Film

    FDA UDI
    CARESTREAM HEALTH, INC.·40889975253349·Medl X-ray Green/MXG Film 13X18cm 100SH

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197182348·Guyon-Bougies, acutely curved, 35.5 c...

    Longeviti ClearFit Cranial Implant

    FDA 510(k)
    FDA Class 2 ·Neurology

    HOFFMANN II ROD TO WIRE COUPLING

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DYNESYS HA PEDICLE+SET SCREW 6.4X50

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code NQP·December 1, 2008

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC·Product code FNL·August 3, 2011

    TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·July 29, 2013

    SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    FDA Enforcement
    Class II ·Ongoing·Cordis Corporation·November 24, 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