7 results
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18ms
·
Sources: EU EUDAMED, US FDA
SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS)
FDA 510(k)
FDA Class 1
·Ophthalmic
Quantum LB
FDA 510(k)
FDA Class 2
·Dental
MEDI-GLOBE ROTA-CUT SPHINCTEROTOME
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 13, 2014
MARQUIS DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·October 8, 2010
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 7, 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