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    TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925016262·PISTON WITH ARMSTRONG PLATINUM RIBBON LOOP .8 M...

    ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ELECTRONIC SPHYGMOMANOMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LOCKING SLIDE HAMMER 400 GRAMS

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZY·October 2, 2020

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 21, 2015

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·May 31, 2013

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD·Product code IKX·October 3, 2014

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·May 31, 2011

    Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code LOD·November 7, 2022

    Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code LOD·November 7, 2022

    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

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013