23 results · 23ms · Sources: EU EUDAMED, US FDA

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Rist 071 Radial Access Guide Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

CORONIS 5MP

FDA 510(k)
FDA Class 2 ·Radiology

PICC CONVENIENCE KIT

FDA 510(k)
FDA Class 2 ·General Hospital

THERMOPHORE

FDA Adverse Event
Malfunction ·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·September 23, 1996

AGILE ESOPHAGEAL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024

GAMMA CAMERA

FDA Adverse Event
Malfunction ·TOSHIBA MEDICAL SYSTEMS OF AMERICA·Product code IYX·April 17, 1992

AGILE ESOPHAGEAL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024

INTELLIVUE INFO CENTER IX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 19, 2023

AGILE ESOPHAGEAL

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

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FDA Adverse Event
Malfunction ·RICHARD WOLF MEDICAL INSTRUMENTS CORP·Product code GEI·May 29, 2015

PATIENT INFORMATION CENTER IX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·May 1, 2024

THERMOPHORE

FDA Adverse Event
Malfunction ·BATTLE CREEK EQUIPMENT CO.·Product code IRT·January 23, 1997

BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIB

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·July 8, 2011

530G INSULIN PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 29, 2014

MECHANICAL (MANUAL) WHEELCHAIR

FDA Adverse Event
Malfunction ·INVAMEX·Product code IOR·July 8, 2013

THERMOPHORE

FDA Adverse Event
BATTLE CREEK EQUIPMENT CO·Product code IRT·September 10, 1996

THERMOPHORE

FDA Adverse Event
Malfunction ·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·December 11, 1996

THERMOPHORE

FDA Adverse Event
Malfunction ·BATTLE CREEK EQUIPMENT CO·Product code IRT·October 24, 1996

THERMOPHORE

FDA Adverse Event
Malfunction ·BATTLE CREEK EQUIPMENT CO.·Product code IRT·December 4, 1996

Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026