BEUDAMED
    18 results · 25ms · Sources: EU EUDAMED, US FDA

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    SAPPHIRE ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AP409 -PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·December 18, 2025

    AP205 - INFUSION SET WITH NON-VENTED SPIKE, 1.2UM FILTER AND NEEDLE Y-SITE

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·June 5, 2024

    AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·June 6, 2024

    AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·June 17, 2024

    AP403 - MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·March 31, 2026

    AP407 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER AND NEEDLELESS Y-SITE

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·March 4, 2026

    ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM

    FDA 510(k)
    FDA Class 2 ·Dental

    3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FOLFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 4, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 27, 2011

    BD INSYTE AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 24, 2024

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025

    POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 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