BEUDAMED
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    ASSURE Wearable ECG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DERMABOND PRINEO SKIN CLOSURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GENZYME OSOM TRICHOMONAS RAPID TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·May 26, 2015

    DUROM US ACETABAR COMPONENT 56/50 P

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·November 13, 2008

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·September 4, 2011

    ON Q PAINBUSTER

    FDA Adverse Event
    Malfunction ·I-FLOW CORP·Product code MEB·July 12, 2013

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025