13 results
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27ms
·
Sources: EU EUDAMED, US FDA
TXR 325 X-RAY CONTROL WITH HIGH VOLTAGE GENERATOR
FDA 510(k)
FDA Class 1
·Radiology
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78602031·Sprint II Bracket Roth .018" max. 2 right
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78602030051·Sprint II Bracket Roth .018" max. 2 right
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78602030101·Sprint II Bracket Roth .018" max. 2 right
Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78602031001·Sprint II Bracket Roth .018" max. 2 right
MODIFICATION TO CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ADAMANT ZIRCONIA DISC
FDA 510(k)
FDA Class 2
·Dental
HOURGLASS
FDA Adverse Event
Injury
·MEDTRONIC·Product code MQP·June 16, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
KARL STORZ
FDA Adverse Event
Other
·KARL STORZ ENDOVISION·Product code KOG·December 1, 2012
UNKNOWN NEXGEN LPS-FLEX FEMORAL COMPONENT
FDA Adverse Event
Malfunction
·ZIMMER INC.·Product code HSA·September 21, 2010
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012