23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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
*
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