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ACN-60A

FDA Adverse Event
Malfunction ·OPHTHALMIC INNOVATIONS INTERNATIONAL, INC.·Product code HQL·June 20, 2005

ACN-60A

FDA Adverse Event
Malfunction ·OPHTHALMIC INNOVATIONS INTL., INC.·Product code HQL·June 20, 2005

PINNACLE R/O II OR RADIFOCUS INTRODUCER II

FDA 510(k)
FDA Class 2 ·Cardiovascular

THE GUARDIAN SYSTEM

FDA Adverse Event
Malfunction ·AVERTIX MEDICAL·Product code QBI·April 14, 2025

THE GUARDIAN SYSTEM

FDA Adverse Event
Malfunction ·AVERTIX MEDICAL·Product code QBI·April 14, 2025

PHAKIC6H 125

FDA Adverse Event
Malfunction ·OPHTHALMIC INNOVATIONS INTL., INC. (OII)·Product code HQL·November 20, 2006

PHAKIC6H 125

FDA Adverse Event
Malfunction ·OPHTHALMIC INNOVATIONS INTL., INC.(OII)·Product code HQL·November 21, 2006

THE GUARDIAN SYSTEM

FDA Adverse Event
Malfunction ·AVERTIX MEDICAL·Product code QBI·April 14, 2025

THE GUARDIAN SYSTEM

FDA Adverse Event
Malfunction ·AVERTIX MEDICAL INC·Product code QBI·April 14, 2025

THE GUARDIAN SYSTEM

FDA Adverse Event
Malfunction ·AVERTIX MEDICAL INC.·Product code QBI·April 14, 2025

TERUMO PINNACLE R/O II INTRODUCER SHEATH

FDA Adverse Event
Injury ·TERUMO MEDICAL CORP.·Product code DYB·July 29, 2021

THE GUARDIAN SYSTEM

FDA Adverse Event
Malfunction ·AVERTIX MEDICAL INC.·Product code QBI·April 14, 2025

THE GUARDIAN SYSTEM

FDA Adverse Event
Malfunction ·AVERTIX MEDICAL INC.·Product code QBI·April 14, 2025

THE GUARDIAN SYSTEM

FDA Adverse Event
Malfunction ·AVERTIX MEDICAL INC·Product code QBI·April 14, 2025

THE GUARDIAN SYSTEM

FDA Adverse Event
Malfunction ·AVERTIX MEDICAL INC·Product code QBI·April 14, 2025

THE GUARDIAN SYSTEM

FDA Adverse Event
Malfunction ·AVERTIX MEDICAL INC·Product code QBI·April 14, 2025

THE GUARDIAN SYSTEM

FDA Adverse Event
Malfunction ·AVERTIX MEDICAL INC·Product code QBI·April 14, 2025

THE GUARDIAN SYSTEM

FDA Adverse Event
Malfunction ·AVERTIX MEDICAL INC·Product code QBI·April 14, 2025

THE GUARDIAN SYSTEM

FDA Adverse Event
Malfunction ·AVERTIX MEDICAL INC.·Product code QBI·April 14, 2025

THE GUARDIAN SYSTEM

FDA Adverse Event
Malfunction ·AVERTIX MEDICAL INC.·Product code QBI·April 14, 2025