BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

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    Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes

    FDA 510(k)
    FDA Class 2 ·Dental

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970560·

    DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PROLYTE ELECTROLYTE ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973479·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970881·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973080·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973707·

    CRIT-LINE BLOOD CHAMBER

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

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 8, 2013

    POLYFORM SYNTHETIC MESH

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTP·October 8, 2014

    8800

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·June 17, 2011

    UNITIP CATHETER FOR HR GI

    FDA Adverse Event
    Injury ·UNISENSOR AG·Product code FFX·August 25, 2014

    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