BEUDAMED
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    STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517637123·CoRoent Ant TLIF PEEK, 13x13x32mm 12°

    HHM

    FDA UDI
    Oticon A/S·05707131259936·H110, MINIBTE 312 WL 85 SIL HHM

    EVERCROSS 0.035 OTW PTA DILATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 9, 2024

    XMAX MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·October 1, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 29, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 20, 2011

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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