BEUDAMED
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    Electronic Pulse Stimulator

    FDA 510(k)
    FDA Class 2 ·Neurology

    Oticon

    FDA UDI
    Oticon A/S·05707131282613·H11V2, BTE 13 WL 85 TC

    PULSAVAC®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024375260·Shower Spray Kit (Low Pressure)

    SHIKANI SPEAKING VALVE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2, SHORT NECK

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·October 25, 2019

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITI·June 6, 2013

    STANDARD INSERT

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD·Product code KWA·June 29, 2011

    CAPIOX RX15 OXYGENATOR

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 8, 2014

    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