3,048 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FREESTYLE LIBRE 2
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC·Product code QLG·March 13, 2024
FREESTYLE LIBRE 2
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC·Product code QLG·April 10, 2023
Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US PT-000429: Cable, Charging, Omnipod 5, Horizon PDM
FDA Enforcement
Class II
·Ongoing·Insulet Corporation·December 14, 2022
Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US PT-000429: Cable, Charging, Omnipod 5, Horizon PDM
FDA Recall
Open, Classified
·Product code QFG·November 14, 2022
PARAGON CRT DUAL AXIS
FDA Adverse Event
Injury
·PARAGON VISION SCIENCES, INC.·Product code NUU·April 6, 2021
PARAGON CRT 100
FDA Adverse Event
Injury
·PARAGON VISION SCIENCES, INC.·Product code NUU·July 24, 2024
ORTHOKERATOLOGY, CRT CONTACTS
FDA Adverse Event
Injury
·UNK·Product code NUU·November 27, 2018
ACUVUE® ABILITI¿ OVERNIGHT
FDA Adverse Event
Injury
·MENICON B.V.·Product code NUU·December 16, 2025
ACUVUE ABILITI¿ OVERNIGHT
FDA Adverse Event
Injury
·MENICON B.V.·Product code NUU·December 23, 2025
PARAGON CRT DUAL AXIS
FDA Adverse Event
Injury
·PARAGON VISION SCIENCES, INC.·Product code NUU·July 18, 2023
PARAGON CRT 100
FDA Adverse Event
Injury
·PARAGON VISION SCIENCES, INC.·Product code NUU·May 28, 2024
PARAGON CRT 100
FDA Adverse Event
Injury
·PARAGON VISION SCIENCES, INC.·Product code NUU·May 10, 2024
ACUVUE® ABILITI¿ OVERNIGHT
FDA Adverse Event
Injury
·MENICON B.V.·Product code NUU·July 13, 2023
ACUVUE ABILITI¿ OVERNIGHT
FDA Adverse Event
Injury
·MENICON B.V.·Product code NUU·July 14, 2023
ACUVUE ABILITI¿ OVERNIGHT
FDA Adverse Event
Injury
·MENICON B.V.·Product code NUU·September 4, 2025
ORTHOKERATOLOGY (ORTHO-K) CONTACT LENSES
FDA Adverse Event
Malfunction
·PARAGON VISION SCIENCES, INC.·Product code NUU·September 22, 2025
ACUVUE® ABILITI¿ OVERNIGHT
FDA Adverse Event
Injury
·MENICON B.V.·Product code NUU·September 2, 2025
PARAGON CRT DUAL AXIS
FDA Adverse Event
Injury
·PARAGON VISION SCIENCES, INC.·Product code NUU·June 21, 2024
PARAGON CRT100
FDA Adverse Event
Injury
·PARAGON VISION SCIENCES, INC.·Product code NUU·September 11, 2021
ACUVUE ABILITI OVERNIGHT THERAPEUTIC LENSES FOR MYOPIA MANAGEMENT
FDA Adverse Event
Malfunction
·MENICON CO. LTD.·Product code NUU·January 2, 2024