22 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TriALTIS Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
SOLSTICE OCT System
FDA 510(k)
FDA Class 2
·Orthopedic
IMP,TSV,3.7,10,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·January 26, 2023
BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 6, 2025
COAGUCHEK S SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JPA·November 7, 2008
S-ROM M HEAD 36MM +6
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code JDI·September 12, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code ITI·July 23, 2013
BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 19, 2025
COREVALVE TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 12, 2018
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 12, 2018
DA VINCI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·August 13, 2024
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·September 11, 2020
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·January 15, 2026
ARROW HEMODIALYSIS KIT: 2-L 15 FR X 27 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code MSD·July 20, 2020
UNKNOWN SOLITAIRE
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·October 9, 2024
UNKNOWN SOLITAIRE
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·October 9, 2024
CELLO BALLOON GUIDE CATHETER
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code DQY·October 9, 2024
CELLO BALLOON GUIDE CATHETER
FDA Adverse Event
Death
·MICRO THERAPEUTICS, INC. DBA EV3·Product code DQY·October 9, 2024
Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172
FDA Enforcement
Class II
·Terminated·Vision RT Ltd·October 10, 2018