7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOF SET, MODELS 111 AND 112
FDA 510(k)
FDA Class 2
·General Hospital
ORTHOPEDIC LOWER EXTREMITY SUSPENSION
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SELECTSECURE
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 10, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 7, 2012
JUVEDERM VOLUMA WITH LIDOCAINE 1ML
FDA Adverse Event
Injury
·ALLERGAN·Product code LMH·June 19, 2015
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