BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    ULCERCARE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VITROS

    FDA UDI
    ORTHO CLINICAL DIAGNOSTICS·10758750033522·VITROS Immunodiagnostic Products hs Troponin I ...

    REPROCESSED ELECTROPHYSIOLOGY CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INSIGHT, MODEL S980000

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

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·January 11, 2013

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·November 18, 2010

    SMALL BATTERY DRIVE

    FDA Adverse Event
    Malfunction ·SYNTHES OBERDORF·Product code HWE·July 3, 2014

    BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection.

    FDA Recall
    Terminated ·Dukal Corp.·Product code FPY·June 1, 2017

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015