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

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Dental Electrical Motor iRoot Pro

FDA 510(k)
FDA Class 1 ·Dental

NEURO VENTION LAMINPLASTY PLATING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

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

MERGE CARDIO

FDA Adverse Event
Malfunction ·MERGE HEALTHCARE SOLUTIONS INC.·Product code LLZ·October 20, 2023

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 28, 2011

UKNOWN ASR FEMORAL HEAD

FDA Adverse Event
Injury ·Product code KWA·June 26, 2013

PARADIGM REAL-TIME INSULIN INFUSION PUMP

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

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

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

TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems·October 10, 2018