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

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    Disposable Pen Injector Assembly

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Q IFA ANA Hep-2 96-Well Test System

    FDA UDI
    ZEUS SCIENTIFIC, INC.·00845533001700·The ZEUS ANA HEp-2 Test System is a prestandard...

    INJECTOR NEEDLE/SNARE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·April 2, 2018

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 1, 2018

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    FDA Adverse Event
    Injury ·BD MEDICAL - DIABETES CARE·Product code FMF·January 31, 2019

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 10, 2014

    PROXIMATE** RH ROTATING HEAD SKIN STAPLER

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

    TOTAL CARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·July 17, 2013

    PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    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