8 results
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18ms
·
Sources: EU EUDAMED, US FDA
RESPIRONICS SECUREASY
FDA 510(k)
FDA Class 1
·Anesthesiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517157454·CoRoent® XLF, 8x18x45mm
MONOCHROME LCD MONITOR, RADIFORCE MODEL GS310
FDA 510(k)
FDA Class 2
·Radiology
Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 6, 2012
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·June 22, 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