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

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    Sapphire Sets

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IMMULISA INTRINSIC FACTOR ANTIBODY ELISA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GC ORAL MOISTURIZING GEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM

    FDA Adverse Event
    Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZF·December 20, 2018

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Injury ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 18, 2018

    HMRS ROT HINGE TIB ROT COMP

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS LIMERICK·Product code HSH·July 18, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 14, 2013

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008

    STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM

    FDA Adverse Event
    Injury ·STIMWAVE TECHNOLOGIES INC.·Product code GZF·April 1, 2019

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Death ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 26, 2018

    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