BEUDAMED
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    TRANSCEND AUTO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NexxZr™ T / D-100-20-NT-C300-SD

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271113375·

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776183950·Side WirePin Cutter TC DA Ang Jaw

    HEMEDEX FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ENDOTRACHEAL TUBE CHANGERS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    COBAS C501

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·May 10, 2007

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 17, 2011

    ZIMMER DERMATOME SCREWDRIVER

    FDA Adverse Event
    Injury ·ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS·Product code HXX·August 21, 2008

    Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.

    FDA Recall
    Terminated ·Zimmer Dental Inc·Product code DZE·January 6, 2014

    ISE SODIUM ELECTRODE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORPORATION·Product code JGS·October 7, 2010

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 23, 2010

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 13, 2010

    Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.

    FDA Enforcement
    Class II ·Terminated·Zimmer Dental Inc·February 5, 2014

    STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·May 8, 2013

    Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·July 16, 2014

    STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·August 8, 2012