7 results
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21ms
·
Sources: EU EUDAMED, US FDA
POLYPOLE
FDA 510(k)
FDA Class 1
·General Hospital
DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Xenocor Xenoscope Laparoscopic System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SURGIPRO 0 30 BLUE C-17
FDA Adverse Event
Injury
·USSC PUERTO RICO·Product code GAW·October 5, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 13, 2014
STAIR PRO - MODEL 6252
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPP·November 8, 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