BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    Elecsys Tacrolimus

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DURABLUE STERILIZATION WRAP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STEM EXTENSION

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·March 29, 2023

    STEMMED NONAUGMENTABLE TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·June 9, 2023

    LCCK NEXGEN ARTICULAR SURFACE WITH LOCKING SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·February 9, 2022

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code GZB·October 10, 2014

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·June 17, 2013

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 24, 2011

    RHYTHMIA HDX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025

    EVOLUT FX VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 29, 2024

    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