29 results
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19ms
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Sources: EU EUDAMED, US FDA
OPTI-FREE EXPRESS LENS DROPS
FDA 510(k)
FDA Class 2
·Ophthalmic
Precisor EXL
FDA UDI
Conmed Corporation·30653405051859·Precisor EXL Coated Disposable Biopsy Forceps, ...
TruLock
FDA UDI
Rmo, Inc.·00885797658296·TRULOCK Primer Activated Adhesive Kit (4ea Syri...
Optos OCT/SLO
FDA UDI
OPTOS PUBLIC LIMITED COMPANY·05057056003856·
GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PORTSETT
FDA 510(k)
FDA Class 2
·General Hospital
DEXTRUS 4136
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·March 12, 2013
HNA MILLENNIUM PATHNET BLOOD BANK TRANSFUSION
FDA Adverse Event
Other
·CERNER CORP·Product code MMH·February 7, 2011
ACCU-CHEK ADVANTAGE
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code NBW·February 18, 2008
EVIS EXERA III BRONCHOVIDEOSCOPE
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code EOQ·August 23, 2024
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 is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. 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 x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the 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.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·November 6, 2013
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
882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors).
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 22, 2017
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 12, 2013