BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    HEMOCHRON THROMBOCHRONOMETER

    FDA 510(k)
    FDA Class 2 ·Hematology

    OrionXR

    FDA 510(k)
    FDA Class 2 ·Radiology

    OTOMAG BONE CONDUCATION HEARING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    GEMSTAR PAIN MGE SNG

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 7, 2014

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code KPE·November 14, 2012

    PRECISION LINK

    FDA Adverse Event
    Malfunction ·Product code NBW·September 13, 2010

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015

    Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 100047194; CD3211-36Q/100004091, 100004093,100019784, 100035620, 100042486, 100047054; CD3215-36/100006995, 100010246, 100010247, 100010249, 100010250, 100012569, 100012570, 100034981, 100046577, 100046802, 60019065; CD3215-36Q/100004059, 100004060, 100004061, 100023304, 100030590, 100033678, 100042492, 100046803, 100046906

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018