BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    LINACwatch, LinacView

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIO-MAT 2000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    AZE VIRTUALPLACE-MR FLOW ANALYSIS SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    VANGUARD ROCC POR FEM S60 L

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·February 3, 2026

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 17, 2013

    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 24, 2011

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·September 23, 2008

    VANGUARD MONO FINNED STM TIB 71X8

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·August 9, 2023

    VANGUARD ROCC POR FEM S60 L

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code JWH·February 20, 2025

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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