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

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    PRIME ZOOM STRETCHER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Embla

    FDA UDI
    S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD·07290013817129·

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690117339·Modular Knee Stem Pilot 9mm x 150mm

    Reef TH

    FDA UDI
    Seaspine Orthopedics Corporation·10889981201531·Interbody, 11mm x 40mm x 9mm, 15 deg

    Reef TA

    FDA UDI
    Seaspine Orthopedics Corporation·10889981193546·Interbody, 11mm x 40mm x 9mm, 15 deg

    Reef TA

    FDA UDI
    Seaspine Orthopedics Corporation·10889981208653·Trial, 11mm x 40mm x 9mm, 15 deg

    Apelo® / Apelo® MIS

    FDA UDI
    ATLAS SPINE, INC.·M68111001400950·5.5mm x 95mm MIS Straight Rod

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 8

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·December 22, 2020

    CENTRAL VISION ANALYZER MODEL 1000

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 4, 2025

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 3, 2014

    UNKNOWN MESH PRODUCT (EWHU)

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·May 31, 2013

    RHEUMATOID FACTOR TEST SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER INC.·Product code DHR·June 25, 2011

    UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KOB·May 2, 2018

    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

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013