BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    CATHETER, SILICONE FOLEY (BARDEX)

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

    RayStation

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRESEP OLIGON OXIMETRY CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·April 18, 2014

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 26, 2012

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·July 9, 2010

    iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code NJT·August 2, 2018

    iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.

    FDA Enforcement
    Class I ·Terminated·Ventana Medical Systems Inc·September 26, 2018

    Model Number U228, VISIONIST CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025