BEUDAMED
    10 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DIODE LASER THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APOLLO GENERATOR

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

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·June 7, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 24, 2011

    AXSYM RUBELLA IGG ANTIBODY

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code LFX·September 10, 2008

    BD VACUTAINER® CPT¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·January 8, 2019

    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

    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