BEUDAMED
    16 results · 7ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Ii × Status: Ongoing × Clear all

    FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic

    FDA Enforcement
    Class II ·Ongoing·Inpeco S.A.·October 15, 2025

    FlexLab (FLX) System. Potassium Test System. in vitro diagnostic

    FDA Enforcement
    Class II ·Ongoing·Inpeco S.A.·October 15, 2025

    SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    FDA Enforcement
    Class II ·Ongoing·Cordis Corporation·November 24, 2021

    SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    FDA Enforcement
    Class II ·Ongoing·Cordis Corporation·November 24, 2021

    SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    FDA Enforcement
    Class II ·Ongoing·Cordis Corporation·November 24, 2021

    SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    FDA Enforcement
    Class II ·Ongoing·Cordis Corporation·November 24, 2021

    SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    FDA Enforcement
    Class II ·Ongoing·Cordis Corporation·November 24, 2021

    SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

    FDA Enforcement
    Class II ·Ongoing·Cordis Corporation·November 24, 2021

    Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. Component: Not a component.

    FDA Enforcement
    Class II ·Ongoing·IMRIS Imaging Inc·January 14, 2026

    LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

    FDA Enforcement
    Class II ·Ongoing·Hill-Rom, Inc.·October 6, 2021

    FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

    FDA Enforcement
    Class II ·Ongoing·Hill-Rom, Inc.·October 6, 2021

    Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

    FDA Enforcement
    Class II ·Ongoing·Hill-Rom, Inc.·October 6, 2021

    LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.

    FDA Enforcement
    Class II ·Ongoing·Hill-Rom, Inc.·October 6, 2021

    Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010

    FDA Enforcement
    Class II ·Ongoing·Hill-Rom, Inc.·February 23, 2022

    Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015

    FDA Enforcement
    Class II ·Ongoing·Hill-Rom, Inc.·February 23, 2022

    OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Model Number: 3156056

    FDA Enforcement
    Class II ·Ongoing·Hill-Rom, Inc.·October 6, 2021