22 results
·
21ms
·
Sources: EU EUDAMED, US FDA
APOLLO MOBILE C ARM SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0103130·Shaver, Closed, 13mm
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033145456·
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033145487·
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345024083·Paddle Shaver, 13mm
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033145425·
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033145470·
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033145449·
XTRA SIGHT
FDA UDI
FGX INTERNATIONAL INC.·00193033145463·
THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR
FDA 510(k)
FDA Class 2
·Immunology
NOVA CORDLESS CURING LIGHT
FDA 510(k)
FDA Class 2
·Dental
BD INSYTE AUTOGUARD SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 14, 2020
ACIST
FDA Adverse Event
Injury
·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·February 10, 2012
ADVANTAGE BALLOON CATHETER INFLATION DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MAV·March 19, 2013
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·March 8, 2011
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·May 11, 2007
ACIST
FDA Adverse Event
Malfunction
·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·April 20, 2007
ACIST
FDA Adverse Event
Injury
·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·February 10, 2012
CELLEX PHOTOPHERESIS SYSTEM
FDA Adverse Event
Malfunction
·MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED·Product code LNR·March 3, 2023
Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
FDA Enforcement
Class II
·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022