BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813034163·Hedstrom Files with Silicone Stops 31mm #30

    NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000

    FDA 510(k)
    FDA Class 2 ·Neurology

    Snap-Off Self-Compressive Screw

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    METASUL, ALPHA INSERT, II/32

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·March 15, 2018

    ENDURON 10D 48OD X 28ID

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HRY·December 2, 2008

    DISPOSABLE HIP BONEC

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW MANSFIELD MANUFACTURING SITE·Product code HAB·September 16, 2011

    ACCENT DR

    FDA Adverse Event
    ST JUDE MEDICAL·Product code NVZ·July 25, 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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013