10 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
FDA Enforcement
Class II
·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·April 19, 2023
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
iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
FDA Enforcement
Class II
·Terminated·SynCardia Systems Inc.·January 9, 2013
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·July 10, 2024
Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014
Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.
FDA Enforcement
Class II
·Terminated·Bayer Corp·June 11, 2014
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015