BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    MuscleView

    FDA 510(k)
    FDA Class 2 ·Radiology

    LCP

    FDA UDI
    Synthes GmbH·10886982166814·LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 3 HOLES...

    NA

    FDA UDI
    MEDTRONIC PS MEDICAL, INC.·00643169497498·SHUNT 24133-1 CSF-DELTA CHMBR PERIT 1.0

    BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER

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

    BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·May 17, 2024

    POSEY KEEPSAFE DELUXE ALARM

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code KMI·September 2, 2011

    INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 10, 2014

    EMERGE?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 22, 2013

    Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF) Distraction System, MatrixORTHOGNATHIC Plating System, and the Matrix MANDIBLE Plating System.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·January 21, 2015

    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