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

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    ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC)

    FDA 510(k)
    FDA Class 2 ·Immunology

    C-PORT - HP POWER INJECTABLE PORT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 31, 2014

    CONSTELLATION WITH LASER

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 22, 2010

    SYSTEM 6 ASEPTIC HOUSING ASSY

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·November 14, 2012

    PROTAPER SHAP. 19MM/SX*NOT CE*

    FDA Adverse Event
    Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKS·November 4, 2025

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015