7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
APEX SUCTION CURETTE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Micromed BRAIN QUICK system
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 29, 2014
MONARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·December 5, 2012
TRILOGY O2
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·June 26, 2015
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021