BEUDAMED
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    REMEX-GR100

    FDA 510(k)
    FDA Class 2 ·Dental

    Philips

    FDA UDI
    Sbo Hearing A/S·05714464058471·HEARLINK 3030 MNR T GR/DG

    NIM Vital, Nerve Integrity Monitor

    FDA 510(k)
    FDA Class 2 ·Neurology

    BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNIFY ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·November 10, 2014

    ZIMMER NEXGEN COMPLETE KNEE SOLUTION LEGACY LPS

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code MBH·September 4, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 22, 2013

    PATIENT INTERFACE NIM4CPB1 NIM 4.0

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·October 28, 2025

    STIMULATOR, ELECTRICAL, EVOKED RESPONSE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·July 31, 2023

    NIM 4.0 CONSOLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·September 5, 2025

    NIM 4.0 CONSOLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·August 2, 2024

    NIM 4.0 CONSOLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·May 20, 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