BEUDAMED
    17 results · 26ms · Sources: EU EUDAMED, US FDA

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    Great Basin Shiga Toxin Direct Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AGC KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304242937·

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100738·SCHOTT EYE SPECULUM WIRE

    NITRILE BLUE POWDERED EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·June 8, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 8, 2014

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 17, 2011

    BD PLASTIC NON-STERILE LUER-LOK¿ TIP SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 28, 2022

    CRIT-LINE BLOOD CHAMBER

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code KOC·July 21, 2018

    BD SYRINGE 5ML LL BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 12, 2024

    BD SYRINGE 5ML LL BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 12, 2024

    BD SYRINGE 5ML LL BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 12, 2024

    BD SYRINGE 5ML LL BNS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 12, 2024

    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; 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