23 results · 21ms · Sources: EU EUDAMED, US FDA

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Oncospace

FDA 510(k)
FDA Class 2 ·Radiology

Activmotion S DTO

FDA 510(k)
FDA Class 2 ·Orthopedic

WATERLASE FOR APICOECTOMY

FDA 510(k)
FDA Class 2 ·Dental

RESOLUTION 360 CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·December 2, 2024

RESOLUTION 360 CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·October 9, 2025

RESOLUTION CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·June 17, 2025

RESOLUTION 360 CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·November 25, 2024

RESOLUTION CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·January 8, 2025

RESOLUTION 360 CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·March 6, 2025

RESOLUTION CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·June 11, 2025

RESOLUTION CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·February 13, 2025

RESOLUTION 360 CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·January 8, 2025

RESOLUTION 360 CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·March 4, 2025

RESOLUTION CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·March 28, 2025

V60 VENTILATOR

FDA Adverse Event
Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·August 25, 2011

SPRING WIRE GUIDE COMPONENT

FDA Adverse Event
Malfunction ·ARROW INTL., INC.·Product code DQX·July 10, 2008

GYNECARE TVT OBURATOR SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·July 12, 2013

TEMA ELBOW SYSTEM

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code JDB·September 26, 2024

RESOLUTION 360 CLIP

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code PKL·April 3, 2025

Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Numbers: 722063, 722221. 2. Azurion 3 M15. Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12. Model Number: 722227. 4. Azurion 5 M20. Model Numbers: 722228, 722281. 5. Azurion 7 B12. Model Numbers: 722067, 722225. 6. Azurion 7 B20. Model Numbers: 722068, 722226. 7. Azurion 7 M12. Model Numbers: 722078, 722223. 8. Azurion 7 M20. Model Numbers: 722079, 722224, 722282.

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·December 12, 2025