8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOLUTION ADMINISTRATION SETS
FDA 510(k)
FDA Class 2
·General Hospital
P.F.C.
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295215745·P.F.C. MODULAR PLUS HEMI WEDGE TRIAL SZ 2 20 DEG
LOCOBASE WOUND AND SKIN EMULSION
FDA 510(k)
FDA Unclassified
·Unknown
Endophys Pressure Sensing Sheath Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPSURE SP NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
C-FLEX POLAR HEAD POSITIONER
FDA Adverse Event
Other
·ALLEN MEDICAL·Product code CCX·November 28, 2012
RUSCH QUICKJET MANUAL JET VENTILATOR
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CBK·September 22, 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