7 results
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25ms
·
Sources: EU EUDAMED, US FDA
SODIUM, POTASSIUM AND CHLORIDE PROCEDURE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO
FDA 510(k)
FDA Class 2
·Immunology
Waterlase Express
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 13, 2014
THERA-I DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code DXY·October 8, 2010
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 29, 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