3,048 results · 29ms · Sources: EU EUDAMED, 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