8 results
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20ms
·
Sources: EU EUDAMED, US FDA
REGULAR PETAL SOFT PLASTIC APPLI. TAMPAX TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981177263·Modular Trial, 18 x 15 x 9mm, 7 Deg Lordosis
HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IQvitals Zone
FDA 510(k)
FDA Class 2
·Cardiovascular
LIGASURE ATLAS HANDSWITCHING 37CM
FDA Adverse Event
Injury
·COVIDIEN LLC·Product code GEI·February 14, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 31, 2012
*
FDA Adverse Event
Malfunction
·MEDARTIS, INC·Product code HWC·June 1, 2015
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