49 results
·
6ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
FDA Enforcement
Class II
·Ongoing·Inpeco S.A.·October 15, 2025
Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·December 8, 2021
Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10284473 (US) and 10488224 (OUS)
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·December 8, 2021
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
Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital Bed Product Usage: Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and in suitable rooms in private residences. They may not, however, be used for transportation purposes. Any deviation from this use is expressly excluded from possible liability claims.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·August 17, 2016
Progressa Bed - AC-powered adjustable hospital bed
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·April 18, 2018
Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·July 1, 2015
Affinity¿ Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·September 10, 2014
Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·July 4, 2012
Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery ) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market. They are not intended for use as general hospital beds.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·August 1, 2012
Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·November 9, 2016
Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated cardboard and plastic banding. When possible these beds are shipped as a quantity of two (2) together as shown with the nylon strapping. These are shipped in standard freight containers. There is no secondary packaging.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·September 14, 2016
Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·June 24, 2015