7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INFLATOR/DEFLATOR PISTON SYRINGE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe
FDA 510(k)
FDA Class 2
·General Hospital
ES-Series
FDA 510(k)
FDA Class 2
·Radiology
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·June 10, 2014
APEX PUSH OVER-THE-WIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·October 7, 2010
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·December 5, 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