BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    CLEARADEX GEL

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

    VERDICT -II BAR/BZO

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    XIA LP POLYAXIAL SCREW 6.5 X 40MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·September 20, 2011

    XIA ROD DIA. 6 X 480

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·June 2, 2011

    XIA BLOCKER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·May 2, 2011

    XIA SCREW 6, 5 X 40

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code MNI·May 11, 2011

    XIA LP POLYAXIAL SCREW 5.5 X 45MM

    FDA Adverse Event
    Injury ·STRYKER SPINE-SWITZERLAND·Product code KWP·September 7, 2016

    XIA POLYAXIAL SCREW 8.5 X 40MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code MNH·May 2, 2011

    XIA BLOCKER

    FDA Adverse Event
    Injury ·STRYKER SPINE BORDEAUX·Product code KWP·May 11, 2011

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·March 27, 2013

    ASR ACETABULAR CUPS 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 6, 2011

    INFANT INTENSIVE CARE SYSTEM

    FDA Adverse Event
    Other ·DRAEGER MEDICAL SYSTEMS, INC. (PNC)·Product code FMT·June 6, 2008

    HUMERAL STEM 12 MM STEM DIAMETER 130 MM STEM LENGTH

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWT·August 25, 2017

    POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWT·August 25, 2017

    XIA LP POLYAXIAL SCREW 6.5 X 50MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·September 20, 2011

    GLENOSPHERE 36 MM DIAMETER

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWT·August 25, 2017

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022