8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
P.F.C.
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295215875·P.F.C. MODULAR PLUS HEMI WEDGE TRIAL SZ 4 10 DEG
Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202
FDA 510(k)
FDA Class 2
·Physical Medicine
BONEGEN - TR
FDA 510(k)
FDA Class 2
·Dental
REVEAL XT
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DSI·June 10, 2014
C-FLEX POLAR HEAD POSITIONER
FDA Adverse Event
Other
·ALLEN MEDICAL·Product code FWZ·November 28, 2012
HEARTMATE II SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORP.·Product code DSQ·September 22, 2010
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