10 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Inogen Rove 6
FDA 510(k)
FDA Class 2
·Anesthesiology
Intrigue
FDA UDI
LANCER ORTHODONTICS, INC.·00817573020126·INTRG WHISP-Z ROTH CUS HK -11T +5A 018 LL
OSTIM
FDA 510(k)
FDA Class 2
·Dental
TONE-A-MATIC
FDA 510(k)
FDA Class 2
·Physical Medicine
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 20, 2025
PORTEX 8.0MM SUCTIONAID TRACHEOSTOMY TUBE
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL LTD.·Product code BTO·October 10, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 31, 2011
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·July 16, 2013
EXCELSIUS
FDA Adverse Event
Injury
·GLOBUS MEDICAL, INC.·Product code OLO·March 12, 2024
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012