BEUDAMED
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    CRYO CHECK FACTOR VII DEFICIENT PLASMA

    FDA 510(k)
    FDA Class 2 ·Hematology

    PEEK Corpectomy

    FDA UDI
    Nuvasive, Inc.·00887517623140·PEEK Corp Core, Ø12x24mm

    TRANSEND EX 14 GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION·Product code DQX·September 23, 2009

    Arctic Sperm Cryopreservation Medium

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP·Product code DQX·October 27, 2009

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 7, 2010

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·July 14, 2010

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010

    BI-METRIC HIP LATERALISED FEMORAL STEM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·March 2, 2017

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·January 26, 2011

    HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 31, 2014

    HEARTMATE VE POWER BASE UNIT

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·September 13, 2007

    TRANSEND GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 27, 2010

    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