19 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
FDA 510(k)
FDA Class 2
·Hematology
12SL ECG ANALYSIS PROGRAM
FDA 510(k)
FDA Class 2
·Cardiovascular
PICCOLO COMPOSITE NAILING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
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
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·October 22, 2014
ONE TOUCH LANCING DEVICE
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·August 4, 2011
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·June 18, 2013
FOGARTY HYDRAGRIP CLAMP
FDA Adverse Event
Injury
·SITE 192369-V. MUELLER/SURGICAL GROUP·Product code DXC·March 5, 1997
INTELLAMAP ORION?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026
PROAQT SENSOR
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025
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
PROAQT SENSOR
FDA Adverse Event
Malfunction
·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025
INTELLAMAP ORION
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DRF·December 12, 2024
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code PKL·September 16, 2021