31 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EZ CONNECT
FDA 510(k)
FDA Class 2
·Dental
CUSTOM PROCEDURE KIT
FDA UDI
MEDIVATORS INC.·40677964003361·CUSTOM PROCEDURE KIT
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014602905·Transfer Board with Safety Notches
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167700003460·
CURE™ ACP
FDA UDI
MEDITECH SPINE, LLC·B167S1700003460·
KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS)
FDA 510(k)
FDA Class 2
·Orthopedic
RADIOCAMERAS EXTRACRANIAL SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
OXYGENATOR
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·August 12, 2025
V 2.0 FIRM EXT PEBAX
FDA Adverse Event
Injury
·CONCENTRIC MEDICAL·Product code NRY·March 12, 2013
RESTORE PRIME ADVANCED
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·February 18, 2011
PHILLIPS
FDA Adverse Event
Malfunction
·PHILLIPS·Product code DXN·February 15, 2008
SMR GLENOID BASEPLATE SMALL-R
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code KWS·July 2, 2021
BrightView SPECT model number 882480 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).
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 12, 2017
Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 5, 2014
BrightView XCT (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
BrightView XCT
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 22, 2017
BrightView XCT , Model Number 882482
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 31, 2019
BrightView XCT, Gamma Camera, Product Code 882482
FDA Enforcement
Class II
·Ongoing·Philips North America·January 17, 2024
BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·September 14, 2016
BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 9, 2016