BEUDAMED
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    RANGE/DENALI/MESA Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707014850·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 31

    5.3MHZ PENCIL PROBE 7'

    FDA UDI
    PARKS MEDICAL ELECTRONICS, INC.·00816787020786·

    Trulink

    FDA UDI
    STATCORP MEDICAL·10841522130472·BP CUFF,SL,NYLON,1T,SMALL ADULT,18-24,HP,EA

    BMR FACE

    FDA 510(k)
    FDA Class 2 ·Neurology

    EXTENDSURE HBFASC CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    WAVEWRITER ALPHA 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 15, 2024

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 8, 2014

    ELECTRODE, PACEMAKER, PERMANENT

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code DTB·June 8, 2013

    TAMPAX TAMPON, VERSION/ABSORBENCY/SCENT UNKNOWN (NOT APPLICABLE) TAMPON 1APPLIC

    FDA Adverse Event
    Death ·TAMBRANDS MANUFACTURING, INC.·Product code HIL·June 23, 2011

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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