BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    Materialise TKA Guide System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EMPOWR Revision Knee

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RithmID-SD Steerable Diagnostic Electrophysiology Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 13MM LENGTH

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·August 23, 2023

    DISCARDIT II SYRINGE W/O NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·March 14, 2019

    COGNIS HE IS-1/DF-1/IS-1

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·November 11, 2008

    TOTALCARE-

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·August 10, 2011

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    FDA Adverse Event
    CARDIAC SCIENCE CORPORATION·Product code MKJ·July 25, 2013

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·March 19, 2019

    CVS Sterile Preserved Saline Solution 12oz, Product SKU#050428-253793. This product is supplied in 12 fl. oz. (355 mL) bottles for use in rinsing of soft (hydrophilic) contact lenses after heat (thermal) disinfection and rinsing of contact lenses following chemical disinfection.

    FDA Recall
    Terminated ·K C Pharmaceuticals Inc·Product code LYL·February 3, 2010

    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