7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
F/LS MCA APPLICATION SOFTWARE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
ENPULSE
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·October 8, 2010
PROSTAR XL SUTURE-MEDIATED CLOSURE
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·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