53 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL
FDA Adverse Event
Injury
·ALCON RESEARCH, LLC - HUNTINGTON·Product code MFK·April 29, 2024
MEDTRONIC NAVIGATION
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC·Product code HAW·May 30, 2019
MEDTRONIC NAVIGATION
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC·Product code HAW·March 1, 2024
ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - HUNTINGTON·Product code MFK·July 4, 2024
ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - HUNTINGTON·Product code MFK·September 10, 2025
ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - HUNTINGTON·Product code MFK·November 22, 2024
ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL
FDA Adverse Event
Injury
·ALCON RESEARCH, LLC - HUNTINGTON·Product code MFK·May 2, 2025
ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL
FDA Adverse Event
Injury
·ALCON RESEARCH, LLC - HUNTINGTON·Product code MFK·May 2, 2025
ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LLC - HUNTINGTON·Product code MFK·January 3, 2025
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018