7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UNIVERSAL ACETABULAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE
FDA 510(k)
FDA Class 2
·Orthopedic
Insulia Diabetes Management Companion
FDA 510(k)
FDA Class 2
·Anesthesiology
PROTECTA XT DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2014
ATTAIN STARFIX
FDA Adverse Event
MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·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