6 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Stereotaxis GenesisX RMN with Navigant Workstation (NWS)
FDA 510(k)
FDA Class 2
·Cardiovascular
Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TRUSELECT Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·November 14, 2014
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·August 31, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 29, 2013