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

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    PERITONEAL CATHETER STABILIZATION DEVICE 5C4381

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

    ETHOX WEIGHTED FEEDING TUBE

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

    BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG

    FDA 510(k)
    FDA Class 1 ·Radiology

    Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 500 ml ADD WATER Kit comes with concentrated Simple2" Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch).

    FDA Recall
    Terminated ·Cygnus Medical·Product code MNL·March 17, 2016

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 19, 2014

    NEXGEN ROTATING HINGE ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·October 19, 2010

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·December 22, 2012

    First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all forms of bioburden.".

    FDA Recall
    Terminated ·Madison Polymeric Engineering·Product code MNL·November 3, 2017