8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PAPANICOLAOU STIAN OG-6
FDA 510(k)
FDA Class 1
·Hematology
RE-ZORB PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
POPS! one Blood Glucose Monitoring System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 30, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 10, 2012
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 19, 2015
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025