BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    SPINEART Navigation Instrument System

    FDA 510(k)
    FDA Class 2 ·Neurology

    FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INNOVASIS CRANIAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD BBL¿ THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·May 16, 2023

    BD BBL¿ THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·May 16, 2023

    BD BBL¿ THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·February 8, 2023

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 10, 2014

    BINOVA CUSTOM 4.0 FLEXTEND TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·September 2, 2011

    MONOPOLAR CAUTERY INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 22, 2013

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    FDA Adverse Event
    Malfunction ·REYNOSE MANUFACTURING·Product code FKX·August 19, 2011

    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