19 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Straumann BLX Ø3.5 mm Implants
FDA 510(k)
FDA Class 2
·Dental
OKAMOTO STUDDED CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ALCO-SCREEN 02
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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
I-STAT E3+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·March 31, 2020
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEM·June 26, 2013
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (UNK SIZE)
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·July 19, 2011
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·September 26, 2008
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