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