BEUDAMED
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    INSTRUMENT CASSETTE (EFCCL1-F)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    7141854

    FDA Adverse Event
    Malfunction ·December 22, 2017

    MPM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ZOLL IVTM QUATTRO CATHETER

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION·Product code NCX·July 27, 2021

    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

    REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·May 19, 2021

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 4, 2014

    OT VERIO IQ METER

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

    HOME CHOICE PRO

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 27, 2011

    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