BEUDAMED
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    RiverLon (Nylon) Suture

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

    SIGNATURE PLANNER; SIGNATURE GUIDES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

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

    SYNCHRON® ASPARTATE AMINOTRANSFERASE PYRIDOXAL-5'-PHOSPHASE (AST) REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CIT·July 7, 2011

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·October 8, 2014

    VENATECH CONVERTIBLE

    FDA Adverse Event
    Malfunction ·B.BRAUN MEDICAL SAS·Product code DTK·January 5, 2018

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    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