7 results
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17ms
·
Sources: EU EUDAMED, US FDA
BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA
FDA 510(k)
FDA Class 1
·Ophthalmic
MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®
FDA 510(k)
FDA Class 2
·General Hospital
REPROCESSED PHACOEMULSIFICATION TIPS
FDA 510(k)
FDA Class 2
·Ophthalmic
VIVA XT
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code NIK·June 10, 2014
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 7, 2010
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC·Product code DRM·October 29, 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