7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MYOGLOBIN ELISA TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
MAGLIFE C/MAGLIFE C PLUS
FDA 510(k)
FDA Class 2
·Cardiovascular
CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Anesthesiology
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·January 18, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
QUICK FLEX LV LEAD
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 9, 2014
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025