BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    b-ONE® Bipolar Head

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197182423·Guyon-Bougies, acutely curved, 35.5 c...

    NEXUS® BONESCALPEL® 25MM, BLUNT BLADE TUBESET

    FDA Adverse Event
    Malfunction ·MISONIX, INC.·Product code LFL·May 21, 2026

    HVT 2.0

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    i-STAT Alinity System with i-STAT Sodium test

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PUMP MMT-715RNAS PRDGM INS SK EN ML PR

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·December 2, 2008

    CURLIN ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code FRN·August 3, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 29, 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