22 results · 29ms · Sources: EU EUDAMED, US FDA

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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