23 results · 24ms · Sources: EU EUDAMED, US FDA

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VitalScan ANS

FDA 510(k)
FDA Class 2 ·Cardiovascular

EASYLOCK OSTEOSYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

THEKEN CORAL SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 19, 2020

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 10, 2025

CONTOUR® XT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 23, 2026

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 21, 2014

HEARTWARE® VENTRICULAR ASSIST SYSTEM

FDA Adverse Event
Malfunction ·HEARTWARE, INC·Product code DSQ·June 26, 2013

THORATEC VENTRICULAR ASSIST DEVICE SYSTEM

FDA Adverse Event
Malfunction ·THORATEC CORP.·Product code DSQ·July 19, 2011

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 1, 2026

CONTOUR® XT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 31, 2025

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 12, 2026

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·September 11, 2025

CD HORIZON ASTUTE SPINAL SYSTEM

FDA Adverse Event
Injury ·MSD DEGGENDORF MFG·Product code NQP·April 16, 2021

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·October 8, 2025

BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code MAI·April 22, 2020

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023

CONTOUR® PLUS

FDA Adverse Event
Injury ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 4, 2025