9 results
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18ms
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Sources: EU EUDAMED, US FDA
C-FLEX PENROSE DRAINAGE TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PULSE
FDA UDI
Nuvasive, Inc.·00195377060297·PULSE NDI Camera Ethernet Cable, Labeled
Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 10, 2014
ESPIN SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEHP FREE LS LF PLUMSET-OL CP D-CHAN
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·March 25, 2014
XIVE S PLUS
FDA Adverse Event
Injury
·FRIADENT GMBH·Product code DZE·November 5, 2012
VOLAR SMARTLOCK DISTAL RADIUS PLATE, STANDARD
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code HRS·September 13, 2010
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015