BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    Tricoglam Home Use

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    VERTE-STACK® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074520674·SPACER 9193008 CRESCENT PEEK 30X8

    ECHO BI-METRIC MICROPLASTY HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304697751·

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101070·WALTON CONJUNCTIVA RETRACTOR

    HALO ABLATION CATHETER, MODEL 90-9100

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

    INZONE DETACHMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025

    Versa-FX®

    FDA UDI
    Zimmer, Inc.·00889024035850·

    ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

    G7 ACETABULAR LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·January 8, 2018

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·October 13, 2008

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 27, 2013

    35 CM BIPOLAR LEAD

    FDA Adverse Event
    Malfunction ·GREATBATCH MEDICAL·Product code DTB·July 21, 2011

    HANDLE ACETABULAR PRESS

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LXH·May 23, 2025

    ACETABULAR PRESSURIZER SMALL

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LXH·May 23, 2025

    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