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

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    SteriTite rigid reusable sterilization container with MediTray Products

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464055180·OTICON PLAY PX 2 MINIRITE R C044

    CELLSEARCH EPITHELIAL CELL CONTROL KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    PATIENT SPECIFIC DISTAL FEMORAL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 2/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 25, 2023

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 19, 2024

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DIP·November 10, 2014

    PROXIMATE ILS CURVED CIR STAPL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 9, 2011

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 17, 2013

    PROXIMAL TIBIA JTS (DISTAL FEMORAL COMPONENT)

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·November 28, 2018

    DISTAL FEMUR JTS

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·October 15, 2018

    DISTAL FEMUR JTS / PROXIMAL TIBIA MIG

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·April 7, 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