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    MINI TIGHTROPE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Clear Readers

    FDA UDI
    Diversified Products, Inc.·00037741113379·

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Injury ·MSD DEGGENDORF MFG·Product code OVD·December 18, 2019

    CLYDESDALE PTC SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MSD DEGGENDORF MFG·Product code MAX·October 17, 2019

    LIFEPAK 12, 20, 500, CR PLUS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    GENISTRONG

    FDA Adverse Event
    Malfunction ·GENICON·Product code GCJ·October 15, 2017

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·May 29, 2013

    SPACEMAKER PREPERITONEAL DIST BALLOON

    FDA Adverse Event
    Malfunction ·USSC PUERTO RICO·Product code GCJ·May 11, 2011

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·December 10, 2018

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

    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

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023