BEUDAMED
    11 results · 24ms · Sources: EU EUDAMED, US FDA

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    RDI DIRECT LDL CHOLESTEROL TEST

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Polystar HK

    FDA UDI
    Merz Dental GmbH·D7091984107·anteriors; shade A3; mould R 69

    INRATIO2 PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 8, 2016

    INRATIO2 PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 8, 2016

    STEREOTACTIC BIOPSY ATTACHMENT

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAP-AID

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INRATIO2 PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 24, 2016

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 28, 2013

    FREESTYLE LITE

    FDA Adverse Event
    Injury ·Product code NBW·February 10, 2011

    SUPER SUCKER SHORT CURVED (BX/20)

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code KDC·December 18, 2013

    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·April 20, 2016