8 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MiniMAX
FDA 510(k)
FDA Class 2
·Orthopedic
SCUBA BILIARY STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EVOLVE EPS ORTHOLOC
FDA 510(k)
FDA Class 2
·Orthopedic
COPIOS PERICARDIUM MEMBRANE
FDA Adverse Event
Injury
·Product code NPL·June 10, 2020
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·October 22, 2014
2.7MM TI CORTEX SCREW SLF-TPNGWITH T8 STARDRIVE RECESS 26MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·June 27, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 4, 2011
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018