7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
BRACHYVISION 6.0
FDA 510(k)
FDA Class 2
·Radiology
PM14 SOFT AIR COMPRESSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Physio Flex Annuloplasty Ring
FDA 510(k)
FDA Class 2
·Cardiovascular
PLUM A+ DRIVER ED 2
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 27, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 4, 2011
CAPSURE SENSE
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025