BEUDAMED
    15 results · 24ms · Sources: EU EUDAMED, US FDA

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    RejuvatoneMD

    FDA 510(k)
    FDA Class 2 ·Neurology

    Trial Cups

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215038908·

    21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM)

    FDA 510(k)
    FDA Class 2 ·Radiology

    OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    UNKNOWN

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·December 15, 2015

    AE-QAS-K521-99

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code JWH·April 22, 2026

    AE-QAS-K521-99

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code JWH·April 22, 2026

    APOLLO GENERATOR

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

    GREENLIGHT HPS LASER SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·October 8, 2014

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code LWS·June 7, 2013

    HOMEPUMP C-SERIES 270ML X 5ML/HR

    FDA Adverse Event
    Malfunction ·HALYARD - IRVINE·Product code MEB·October 15, 2015

    PREVENA PLUS INCISION MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC·Product code OMP·September 24, 2021

    PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·July 19, 2019

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    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