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

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    DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    artegral life

    FDA UDI
    Merz Dental GmbH·D7091993465·anteriors; shade D3; mould BXL

    FUSION SYSTEM

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

    CorticaLINK Spinal Fusion Platform

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ICON 25 HCG (COMBO CASSETTE)

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·March 16, 2017

    MICROFRANCE® INSTRUMENT

    FDA Adverse Event
    Malfunction ·XOMED MICROFRANCE MFG·Product code GEI·July 21, 2014

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    FDA Adverse Event
    C.T.M. HOMECARE PRODUCT, INC·Product code INI·March 7, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·August 8, 2014

    15CC HYDROSET INJECTABLE CEMENT

    FDA Adverse Event
    Other ·STRYKER ORTHOPAEDICS LIMERICK·Product code GXP·February 11, 2011

    ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 30, 2015

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021