7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANESTHETIC GAS MONITOR SYS
FDA 510(k)
FDA Class 2
·Anesthesiology
VONFLEX S BITE
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO CAREMATIX WELLNESS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
M2A-MAGNUM MOD HEAD SZ 48MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 30, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·November 20, 2012
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 12, 2015
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