FDA.reportPublic FDA data

Teladoc Health, Inc. - Lewisville

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30216114143021611414Teladoc Health, Inc. - Lewisville1N2027-01-011945 LAKEPOINTE DRIVE Lewisville TX US 75057

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3192181831975637K243060TeleRPM Gen2 Blood Glucose Monitoring SystemNBW2025-01-30
3192181121192132K241351Blood Pressure Monitor (TMB-2092-G)DXN2024-08-21
3192181475287738K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)QRL2022-07-06
3192181520398727K202891Blood Pressure MonitorDXN2021-03-09
3192181940541875K133584IN TOUCH BLOOD GLUCOSE MONITORING SYSTEMCGA2014-09-08
3192181036734075K131395TRANSTEK BLOOD PRESSURE MONITORDXN2013-06-19
3192181174352907DEN170088Dexcom G6 Continuous Glucose Monitoring SystemQBJ2018-03-27
3192181626443580
3192181702662286
3192181872216274
3192182028326456

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXN32024-08-21
NBW12025-01-30
QRL12022-07-06
QBJ12018-03-27
CGA12014-09-08