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

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    Idys ALIF ZP 3DTi

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123830·K-WIRE - DOUBLE TROCAR 1.6mm DIA x 200mm

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111282164·MARTIN TISS FORCEPS 7X8 9"

    ELECSYS HCG+B CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SENSEI X ROBOTIC CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DUETTO MT

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·April 14, 2022

    M2A-MAGNUM MODULAR HEAD SIZE 50MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 27, 2013

    VICTORY XL SR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·January 13, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    PROAQT SENSOR

    FDA Adverse Event
    Malfunction ·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025

    ENDURANT II STENT GRAFT

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·September 18, 2019

    PROAQT SENSOR

    FDA Adverse Event
    Malfunction ·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 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