BEUDAMED
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    SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902998034·INSTRUMENT 6971467 RAIL PUNCH 7MMX16MM

    BioZorb Marker GOLD / LP Marker GOLD

    FDA 510(k)
    FDA Class 2 ·Radiology

    VARISOURCE IX HDR AFTERLOADER

    FDA 510(k)
    FDA Class 2 ·Radiology

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·February 21, 2013

    STAIR PRO - MODEL 6252

    FDA Adverse Event
    Injury ·STRYKER CORP, MEDICAL DIV.·Product code FPO·January 19, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 31, 2014

    Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid flow.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·April 28, 2021