7 results
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17ms
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Sources: EU EUDAMED, US FDA
MODEL 7500/000 KETTLER HOLIDAY SOLAR SUN TANNING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UreTron MultiProbe Lithotripter System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW
FDA 510(k)
FDA Class 2
·Orthopedic
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2014
BARD PARKER
FDA Adverse Event
Injury
·ASPEN SURGICAL PRODUCTS, INC.·Product code GES·June 20, 2015
UNKNOWN NEXGEN LPS-FLEX FEMORAL COMPONENT
FDA Adverse Event
Malfunction
·ZIMMER INC·Product code HSA·September 21, 2010
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