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

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INSTATRAK

FDA Adverse Event
Malfunction ·VISUAL IZATION TECHNOLOGY,INC.·Product code LLZ·February 6, 2002

INSTATRAK STRAIGHT ASPIRATOR

FDA Adverse Event
Malfunction ·VISUALIZATION TECHNOLOGY, INC.·Product code MGI·May 12, 1997

INSTATRAK STRAIGHT ASPIRATOR

FDA Adverse Event
Malfunction ·VISUALIZATION TECHNOLOGY, INC.·Product code MGI·February 24, 1997

INSTATRAK STRAIGHT ASPIRATOR

FDA Adverse Event
Malfunction ·VISUALIZATION TECHNOLOGY, INC.·Product code JCX·January 7, 1997

INSTATRAK STRAIGHT ASPIRATOR

FDA Adverse Event
Malfunction ·VISUALIZATION TECHNOLOGY, INC.·Product code MGI·March 19, 1997

INSTATRAK ASPIRATOR

FDA Adverse Event
Malfunction ·VISUALIZATION TECHNOLOGY INC.·Product code LLZ·February 18, 1997

INSTATRAK STRAIGHT ASPIRATOR

FDA Adverse Event
Malfunction ·VISUALIZATION TECHNOLOGY INC.·Product code MGI·January 24, 1997

INSTATRAK

FDA Adverse Event
Malfunction ·VISUALIZATION TECHNOLOGY, INC.·Product code LLZ·November 17, 1999

INSTATRAK

FDA Adverse Event
Malfunction ·VISUALIZATION TECHNOLOGY, INC.·Product code LLZ·November 17, 1999

INSTATRAK

FDA Adverse Event
Injury ·VISUALIZATION TECHNOLOGY, INC.·Product code LLZ·January 15, 1998

CINEMAVISION A/V SYSTEM

FDA Adverse Event
Injury ·RESONANCE TECHNOLOGY, INC.·Product code LNH·July 20, 2012

OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.

FDA Enforcement
Class III ·Terminated·OraSure Technologies, Inc.·April 27, 2016

AEH-4 LITHOTRIPTER

FDA Adverse Event
Malfunction ·NORTHGATE TECHNOLOGIES, INC.·Product code FFK·July 9, 2008

Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP

FDA Enforcement
Class I ·Ongoing·Baxter Healthcare Corporation·January 22, 2025

OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·April 9, 2025

OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·January 5, 2026

OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·April 11, 2025

THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·April 17, 2019

OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·March 22, 2024

WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY

FDA Adverse Event
Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·December 8, 2021