7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AML II TITANIUM ACETABULUM PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO MYALLERGY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENFit enteral syringe
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VIVA XT
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NIK·June 10, 2014
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 8, 2010
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 31, 2012
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