BEUDAMED
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    PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690125488·Modular Knee Stem Pilot 19mm x 75mm

    BD ULTRA FINE PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·June 1, 2021

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·September 6, 2002

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·May 18, 2020

    EAGLE ANTERIOR CERVIAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·October 3, 2014

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·May 31, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 25, 2011

    BD PHASEAL PROTECTOR P50J

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·July 7, 2023

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 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