7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
OMNICOR PROGRAMMER MODEL 222A
FDA 510(k)
FDA Class 3
·Cardiovascular
SYNERVIEW MODEL 6478
FDA 510(k)
FDA Class 2
·Radiology
External Moisturizing Gel
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 24, 2014
3007566237-2012-02382
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·October 4, 2012
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 22, 2010
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025