16 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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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