BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    MyShoulder Planner (5.3SSWPL)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STRAIGHT IMPACTOR M6

    FDA UDI
    FOURNITURES HOSPITALIERES INDUSTRIE·03661489412929·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694023016·FPS 2.7 NC Fusion Plate Large

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694077606·FPS 2.7 NC Fusion Large Plate Sterile Qty 2

    TRAUS SIP20

    FDA 510(k)
    FDA Class 1 ·Dental

    Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IMP,TSV,4.7,16,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·September 24, 2021

    ANGIO-SEAL DEVICE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL·Product code MGB·November 20, 2008

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011

    DIMENSION EXL WITH LM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code DHA·July 22, 2013

    INSYTE AUTOGUARD YEL 24GA X 0.75IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·June 14, 2024

    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