BEUDAMED
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    MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 60mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665008913·

    Secure-Loop 60 mm

    FDA UDI
    XIROS LTD·05060267131515·

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710410240600·Anterior Closing Wedge Osteotomy Guide, 24mm x ...

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710420240600·Anterio Lateral Closing Wedge Osteotomy Guide, ...

    ASTOFLO

    FDA 510(k)
    FDA Class 2 ·Hematology

    MICROAIRE 1000E SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    UNKNOWN EXPLOR LOCKING SCREW

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWI·March 27, 2013

    ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 11, 2011

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·April 5, 2008

    11MM/130 DEG TI CANN TROCH IXATION NAIL 400MM/RIGHT-STER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HSB·May 18, 2015

    11.0MM TI HELICAL BLADE 95MM-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES ELMIRA·Product code HSB·May 18, 2015

    BUTTRESS/COMPRESSION NUT FOR 357.369

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code HST·May 15, 2015

    PERCUTANEOUS INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS

    FDA Adverse Event
    Injury ·SYNTHES HAGENDORF·Product code LXH·May 15, 2015

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    FDA Adverse Event
    Injury ·SYNTHES HAGENDORF·Product code FZX·May 15, 2015

    PERCUTANEOUS CANN CONNECTING SCREW F/TROCH FIXATION NAILS

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code LXH·May 15, 2015

    BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code FZX·May 15, 2015

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018