18 results · 6ms · Sources: EU EUDAMED, US FDA

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Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2

FDA Enforcement
Class II ·Ongoing·Beckman Coulter Inc.·July 31, 2024

namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041; g) CONVENIENCE KIT, REF 60120336; h) LEFT HEART KIT, REF 60131446; i) 3 VALVE MANIFOLD OFF KIT WITH SQUEEZE CONTRAST CONTROLLER AND PROTECTION STATION, REF 60140798; j) CONVENIENCE KIT, REF 60142592; k) LEFT HEART KIT, REF 60183972; l) FOUR VALVE MANIFOLD KIT, REF 60210209; m) RIGHT HEART KIT, REF 60210862; n) LEFT HEART KIT, REF 600705710; o) CONVENIENCE KIT, REF 600803410; p) TUBING KIT; REF 601322913; q) LEFT HEART KIT, REF 60032582A

FDA Enforcement
Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·May 22, 2024

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only

FDA Enforcement
Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only

FDA Enforcement
Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only

FDA Enforcement
Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only

FDA Enforcement
Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only

FDA Enforcement
Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only

FDA Enforcement
Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only

FDA Enforcement
Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only

FDA Enforcement
Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only

FDA Enforcement
Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses

FDA Enforcement
Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses

FDA Enforcement
Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses

FDA Enforcement
Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact lenses

FDA Enforcement
Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact lenses

FDA Enforcement
Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses

FDA Enforcement
Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020

TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses

FDA Enforcement
Class II ·Ongoing·Chengdu Ai Qin E-commerce Co., Ltd·August 5, 2020