7 results
·
34ms
·
Sources: EU EUDAMED, US FDA
MODEL 6500 EXTRACTION IRRIGATION SYS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
QUICK-CHECK
FDA 510(k)
FDA Class 2
·Cardiovascular
STIMULATOR, NERVE, TRANSCUTANEOUS
FDA 510(k)
FDA Class 2
·Neurology
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 5, 2014
EXTERNAL PULSE GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·October 15, 2012
CLEAR, PVC CONTRAST INJECTION TUBING
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DXJ·August 6, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025