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

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    Sofia Influenza A+B FIA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LACTOSORB® SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036056070·

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707014669·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 12

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528127995·3.0 X 12mm Cannulated Headless Screw, T10

    Softcheck

    FDA UDI
    STATCORP MEDICAL·10841522130441·BP CUFF,SL,SOFT,1T,CHILD,12-16,HP,EA

    Trulink

    FDA UDI
    STATCORP MEDICAL·10841522130519·BP CUFF,SL,SOFT,1T,CHILD,12-16,HP,5/BG

    FIDIS VASCULITIS, MODEL MX007

    FDA 510(k)
    FDA Class 2 ·Immunology

    EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    980 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·October 8, 2014

    PALMAZ GENESIS OPTA PRO

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code FGE·June 8, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DRY·June 17, 2011

    Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    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

    Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·November 1, 2023

    Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 2088026-043, e) 2088026-044, f) 2088026-115, g) 2088026-132, h) 2088026-306, i) 2088026-308, j) 2088026-406, k) 2088026-506, l) 2088026-613, m) 2088026-713, n) 2088026-714, o) 2088026-723, p) 2099714-001, q) 2100169-001, r) 2100491-006, s) 2102675-010, t) 2102676-001, u) 2104867-044, v) 2104867-045; Radiological Image Processing System

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·May 10, 2023

    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019

    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

    Alcon Custom Ophthalmic Surgical Procedure Packs

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LLC·April 7, 2021