11 results
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24ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process.
FDA Enforcement
Class III
·Terminated·Trumpf Medical Systems·November 13, 2013
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numbers: 701072780; 701048012
FDA Enforcement
Class III
·Ongoing·Maquet Medical Systems USA·December 27, 2023
The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·September 26, 2012
Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma.
FDA Enforcement
Class III
·Terminated·Fujifilm Medical Systems U.S.A., Inc.·February 3, 2021
Ingenuity Core Computed Tomography X-ray system, Model 728321
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016
Ingenuity Core 128 Computed Tomography X-ray system, Model 728323
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016
Brilliance ICT SP Computed Tomography X-ray system, Model 728311
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016
Brilliance iCT Computed Tomography X-ray system, Model 728306
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016
Ingenuity CT Computed Tomography X-ray system, Model 728326
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016
IQon Spectral CT Computed Tomography X-ray system, Model 728332
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·November 23, 2016
BrightView X 3/8 model number 882478 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only). BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT imaging system should only be used by trained healthcare professionals.
FDA Enforcement
Class III
·Terminated·Philips Medical Systems (Cleveland) Inc·April 12, 2017