20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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