BEUDAMED
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    FIBRO-TEC TEST KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    Trident II Acetabular System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ECSCOPE 100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 5, 2014

    CONSULTA CRT-P

    FDA Adverse Event
    Malfunction ·MEDTRONIC S.A.·Product code NVZ·October 15, 2012

    ENRHYTHM DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DXY·August 10, 2010

    5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code FPA·December 24, 2013

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025