112 results · 66ms · Sources: EU EUDAMED, US FDA

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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