BEUDAMED
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    Reprocessed PentaRay Nav eco High-Density Mapping Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528103579·7.0 x 85mm Cannulated Screw, 16mm Thd

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528107935·7.0 x 85mm Cann Screw 16Thd Sterile 2Pk

    MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES

    FDA 510(k)
    FDA Class 1 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 21, 2025

    TOSHIBA Kalare Diagnostic X-Ray System K110785

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013

    ELECTRIC DERMATOME HANDPIECE

    FDA Adverse Event
    Injury ·ZIMMER SURGICAL·Product code GFD·June 20, 2013

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·July 26, 2011

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·September 24, 2008

    TOSHIBA Kalare Diagnostic X-Ray System K110785

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·July 17, 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