BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    GAMMA PI BLOOD GROUP SUBSTANCE

    FDA 510(k)
    FDA Class 2 ·Hematology

    N/A

    FDA UDI
    inomed Medizintechnik GmbH·EINO8025349·ZD biopsy probe 2.5mm working length 190mm

    ACUMED

    FDA UDI
    Acumed LLC·10806378102349·Multi Parallel Wire Targeting Guide

    ETEST VORICONAZOLE 0.002-32 UG/ML

    FDA 510(k)
    FDA Class 2 ·Microbiology

    EUPALAMUS DEFLECTABLE STYLET, MODEL 01545

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCENT MRI DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·May 9, 2014

    NIGHT GUARD

    FDA Adverse Event
    Malfunction ·RANIR LLC·Product code OBR·October 19, 2012

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 28, 2015

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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