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

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    COULTER FLOW SET

    FDA 510(k)
    FDA Class 2 ·Hematology

    SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY

    FDA 510(k)
    FDA Unclassified ·Unknown

    SELECTIVE INFUSION II CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 5, 2013

    OCTRODE PERCUTANEOUS LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL -NEUROMODULATION DIV.·Product code LGW·December 15, 2010

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 18, 2014

    11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code FZX·May 4, 2017

    11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code FZX·May 4, 2017

    SYNFIX MINI-OPEN IMPLANT COUPLING

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·February 3, 2016

    8.5MM/3.2MM WIRE GUIDE FOR RECON LOCKING

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code FZX·May 3, 2017

    RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code FZX·May 4, 2017

    11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code FZX·May 3, 2017

    8.5MM/3.2MM WIRE GUIDE FOR RECON LOCKING

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code FZX·May 4, 2017

    8.5MM/3.2MM WIRE GUIDE FOR RECON LOCKING

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code FZX·May 4, 2017

    Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·March 25, 2015