BEUDAMED
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    Piezosurgery White

    FDA 510(k)
    FDA Class 2 ·Dental

    SR PIP

    FDA UDI
    Stryker GmbH·00886385019857·SIZE 2: PIP PROXIMAL BROACH ASSEMBLY (GREEN)

    OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NMI IC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM

    FDA Adverse Event
    Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZF·December 20, 2018

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 14, 2013

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    FDA Adverse Event
    Injury ·DEXCOM, INC.·Product code MDS·July 14, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·September 17, 2008

    STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM

    FDA Adverse Event
    Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZF·April 1, 2019

    EVEREST ® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·STRYKER-SPINE·Product code LXH·September 9, 2019

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

    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