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

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    DIGILAB 350 THE KRAKAU PERIMETER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 -40 M

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code MRA·February 9, 2021

    DESENS-IONOMER

    FDA 510(k)
    FDA Class 2 ·Dental

    EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SIG MOD TIB TRAY CEM COCR 4

    FDA Adverse Event
    Injury ·DEPUY IRELAND REG. # 9616671·Product code JWH·May 27, 2014

    RELION PRIME BLOOD GLUCOSE SYSTEM

    FDA Adverse Event
    Injury ·ARKRAY, INC.·Product code NBW·November 14, 2012

    HOLLISTER

    FDA Adverse Event
    Malfunction ·HOLLISTER, INC.·Product code EXB·September 4, 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