8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
WELCON LIGHT HANDLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756586191·CLOSED THORACOTOMY TRAY
HOLTER CARDIOGRAPHY SYS 6201
FDA 510(k)
FDA Class 2
·Cardiovascular
POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000
FDA 510(k)
FDA Class 2
·Cardiovascular
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 23, 2014
AXIALIF 2L
FDA Adverse Event
Injury
·TRANS1·Product code KWQ·November 9, 2010
OCEAN CHEST DRAIN
FDA Adverse Event
Malfunction
·ATRIUM MEDICAL CORPORATION·Product code KDQ·November 30, 2012
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021