7 results
·
34ms
·
Sources: EU EUDAMED, US FDA
AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COMFORM ABSORBANT INCONTINENCE PADS
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
PRESSURE MODULE 5M1247
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 5, 2014
EXTERNAL PULSE GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·October 15, 2012
SECURA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·August 10, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025