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

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    PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QKP·November 24, 2021

    Alleset

    FDA UDI
    GRI Medical & Electronic Technology Co., Ltd.·16931918132105·Non-woven_Full Body_Oval Aperture Drape_W/ doub...

    Endo-Model Knee System - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575378753·Surgical implant template, reusable - Endo Mode...

    Endo-Model Knee System - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575344413·Surgical implant template, reusable - Endo Mode...

    66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TOMOPHASE OCTIS

    FDA 510(k)
    FDA Class 2 ·Radiology

    APOLLO GENERATOR

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code GWG·June 11, 2015

    DEPUY SYNTHES UNIVERSAL HANDLE

    FDA Adverse Event
    Injury ·DEPUY SYNTHES·Product code LXH·October 2, 2014

    FAST-CATH HEMO INT SWARTZ SL1 TRANSSEPTAL 8F

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC. (AF-MINNETONKA)·Product code DYB·June 5, 2013

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 22, 2011

    Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 19, 2012

    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 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

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020