8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SERIES TEN THOUSAND MASTER
FDA 510(k)
FDA Class 2
·Ophthalmic
P.F.C.
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295216285·P.F.C. MODULAR PLUS STEP TRIAL SZ 2.5 10mm
RETAIN RADIOLUCENT SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
CROWN DELTA SILICONE IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
MONOPOLAR CURVED SCISSORS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·October 8, 2010
LCS COMP RP INSERT STD+ 12.5MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·December 7, 2012
ATTAIN STABILITY
FDA Adverse Event
Malfunction
·EOC HEERLEN DISTRIBUTION CTR·Product code OJX·June 10, 2014
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