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

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    LOGIQ V1/ LOGIQ V2

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    IND URINARY TRACT INFECTION (UTI) TEST STRIPS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ROTALINK? PLUS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code MCX·October 8, 2014

    RELIA SR

    FDA Adverse Event
    Malfunction ·MEDTRONIC SINGAPORE OPERATIONS·Product code NVZ·June 8, 2013

    HEARTMATE II LVAD

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·June 28, 2011

    HEMOSIL HIT-AB(PF4-H)

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

    HEMOSIL HIT-AB(PF4-H)

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

    HEMOSIL HIT-AB(PF4-H)

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    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