7 results
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20ms
·
Sources: EU EUDAMED, US FDA
ADVANCED PERFORM HOLLOW FIBER DIALYZER, 019752-5
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OTC TENS Device, Model PTS-IV
FDA 510(k)
FDA Class 2
·Neurology
START IT WITH & WITHOUT I.V. CATH. UNIT
FDA 510(k)
FDA Class 2
·General Hospital
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 13, 2014
KAPPA 900 DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DXY·October 8, 2010
ACCU-CHECK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·November 28, 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