7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERF-GEN Pulsatile Perfusion Solution
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POLY STAT HCG DIPSTICK TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MySpine WebPlanner & MyBalance
FDA 510(k)
FDA Class 2
·Radiology
X3 TRIATHLON INSERT PS#2 9MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·November 3, 2014
SMART CONTROL NITINOL STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code FGE·August 24, 2011
AFFINITY BIRTHING BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code HDD·July 1, 2013
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