112 results
·
66ms
·
Sources: EU EUDAMED, US FDA
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
FDA Enforcement
Class II
·Terminated·Sensus Healthcare, Inc.·March 15, 2023
TECNIS SYMFONY
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code POE·August 20, 2019
TECNIS SYMFONY
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code POE·May 11, 2018
BIOTENE ORALBALANCE GEL
FDA Adverse Event
Other
·GLAXOSMITHKLINE·Product code LFD·January 7, 2010
TECNIS IOL
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code POE·May 21, 2022
TECNIS IOL
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·July 7, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·November 22, 2022
TECNIS SIMPLICITY
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·February 15, 2023
TECNIS IOL
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code MJP·July 3, 2024
TECNIS IOL
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·June 30, 2022
Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
FDA Recall
Terminated
·Sensus Healthcare, Inc.·Product code JAD·February 10, 2023
TECNIS 1-PIECE
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQL·November 21, 2019
TECNIS IOL
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·July 16, 2021
TECNIS SIMPLICITY
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·June 9, 2025
TECNIS IOL
FDA Adverse Event
Malfunction
·AMO PUERTO RICO MFG. INC.·Product code HQL·February 18, 2021
TECNIS ODYSSEY IOL
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code MFK·July 1, 2025
TECNIS IOL
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·July 21, 2022
TECNIS SIMPLICITY
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·January 13, 2026
TECNIS SYMFONY
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code POE·November 26, 2020
TECNIS SYMFONY
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code POE·November 26, 2020