10 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Sbo Hearing A/S·05714464028696·OTICON MORE 3 MINIRITE T C090 DEMO
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022403·365 micron core/730 micron OD Luer Lock Diode L...
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036035624·
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
FDA 510(k)
FDA Class 2
·Microbiology
GROMAN PREPMASTER
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
DA VINCI S SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL, INC.·Product code NAY·November 7, 2008
UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·September 1, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM INC.·Product code MDS·July 16, 2013