17 results
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31ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OneRF Ablation System
FDA 510(k)
FDA Class 2
·Neurology
BODIHEALTH SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
CONTOUR® PLUS BLUE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 13, 2025
TRANSVAGINAL MESH
FDA Adverse Event
Injury
·GYNECARE·Product code OTO·November 2, 2014
WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code MAF·September 1, 2011
PELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTM·July 12, 2013
CONTOUR® PLUS BLUE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·February 11, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 23, 2025
CONTOUR® CARE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 13, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 24, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 23, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 24, 2025
CONTOUR® CARE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 7, 2025
VITEK® REVEAL¿ SENSOR PANEL
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·June 24, 2025
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022