30 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IntellaMap Orion High Resolution Mapping Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
INTELLAMAP ORION?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·May 12, 2026
INTELLAMAP ORION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 15, 2025
INTELLAMAP ORION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 29, 2026
INTELLAMAP ORION?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 17, 2026
INTELLAMAP ORION?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026
INTELLAMAP ORION?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 1, 2026
INTELLAMAP ORION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·November 21, 2024
INTELLAMAP ORION?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·February 26, 2026
INTELLAMAP ORION
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·December 12, 2024
K-Systems
FDA UDI
Coopersurgical, Inc.·00888937025033·G95 Mini Incubator
SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER
FDA 510(k)
FDA Class 2
·Radiology
CARD IQ ANALYSIS II
FDA 510(k)
FDA Class 2
·Radiology
NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED LPS-FLEX ARTICULA
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code JWH·October 31, 2008
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 23, 2011
UNK HIP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 11, 2013
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP JAPAN
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code GTY·October 23, 2025
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP JAPAN
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code GTY·October 23, 2025
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP JAPAN
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code GTY·September 25, 2025