18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ceevra Reveal 2.0
FDA 510(k)
FDA Class 2
·Radiology
VERCISE GEVIA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·August 28, 2024
SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING
FDA 510(k)
FDA Class 2
·Radiology
SPINAL SPHERE SYSTEM
FDA 510(k)
FDA Class 3
·Unknown
OPTICROSS HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·March 28, 2025
OPTICROSS? HD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 7, 2025
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 20, 2022
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 22, 2025
OPTICROSS? HD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 11, 2025
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·April 3, 2025
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·December 11, 2025
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 16, 2025
OPTICROSS? HD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·January 13, 2026
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 7, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 23, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·September 27, 2014
OPTICROSS? HD
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·May 22, 2025
OPTICROSS? HD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·February 26, 2025