FDA.reportPublic FDA data

TANDEM DIABETES CARE, INC.

Matched from indexed company URL: TANDEM DIABETES CARE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30079812853007981285TANDEM DIABETES CARE, INC.1N2026-01-0112400 High Bluff Drive San Diego CA US 92130
30137568113013756811Tandem Diabetes Care, INC.1N2026-01-0110151 Barnes Canyon Road 10151 Barnes Canyon Road San Diego CA US 92121
30165408763016540876TANDEM DIABETES CARE, INC.1N2026-01-016495 Marindustry Place San Diego CA US 92121
30262668333026266833Tandem Diabetes Care Europe B.V.1N2026-01-01359 Schiphol Boulevard Schiphol Noord-Holland NL 1118BJ
30273273023027327302TANDEM DIABETES CARE, INC.1N2026-01-012 Wrigley Ste 100 Irvine CA US 92618
30327464813032746481TANDEM DIABETES CARE, INC.1N2026-01-015995 Pacific Center Blvd Ste 104 San Diego CA US 92121

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1373801753491219P180008t:slim X2 Insulin Pump with Basal-IQ TechnologyOZO2018-06-21
2374911753491219P180008t:slim X2 Insulin Pump with Basal-IQ TechnologyOZO2018-06-21
2092401753491219P180008t:slim X2 Insulin Pump with Basal-IQ TechnologyOZO2018-06-21
2092401663373693P140015T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGMOYC2015-09-08
1373801663373693P140015T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGMOYC2015-09-08
1373801894642238K253074Tandem Mobi insulin pump with interoperable technologyQFG2025-11-06
3423181099192857K251854SteadiSet infusion setFPA2025-08-06
2374911648536408K241078Tandem Mobi Insulin Pump with interoperable technologyQFG2024-07-26
3309501648536408K241078Tandem Mobi Insulin Pump with interoperable technologyQFG2024-07-26
2092401648536408K241078Tandem Mobi Insulin Pump with interoperable technologyQFG2024-07-26
1373801648536408K241078Tandem Mobi Insulin Pump with interoperable technologyQFG2024-07-26
3309501922326382K240309Tandem Mobi insulin pump with interoperable technologyQFG2024-03-21
2092401922326382K240309Tandem Mobi insulin pump with interoperable technologyQFG2024-03-21
2374911922326382K240309Tandem Mobi insulin pump with interoperable technologyQFG2024-03-21
1373801922326382K240309Tandem Mobi insulin pump with interoperable technologyQFG2024-03-21
1373801879226423K232382Control-IQ TechnologyQJI2023-11-03
2374911879226423K232382Control-IQ TechnologyQJI2023-11-03
2092401879226423K232382Control-IQ TechnologyQJI2023-11-03
1373801833868677K232380t:slim X2 Insulin Pump with Interoperable TechnologyQFG2023-11-03
3309501833868677K232380t:slim X2 Insulin Pump with Interoperable TechnologyQFG2023-11-03
2092401833868677K232380t:slim X2 Insulin Pump with Interoperable TechnologyQFG2023-11-03
2374911833868677K232380t:slim X2 Insulin Pump with Interoperable TechnologyQFG2023-11-03
1373801358118247K223213Tandem Mobi Insulin Pump with Interoperable TechnologyQFG2023-07-10
3309501358118247K223213Tandem Mobi Insulin Pump with Interoperable TechnologyQFG2023-07-10
2092401358118247K223213Tandem Mobi Insulin Pump with Interoperable TechnologyQFG2023-07-10
2374911358118247K223213Tandem Mobi Insulin Pump with Interoperable TechnologyQFG2023-07-10
3309501153134609K203234t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)QFG2022-02-15
1373801153134609K203234t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)QFG2022-02-15
3291051153134609K203234t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)QFG2022-02-15
2092401153134609K203234t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)QFG2022-02-15
2374911153134609K203234t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)QFG2022-02-15
2374911388382873K201214t:slim X2 Insulin Pump with Interoperable TechnologyQFG2020-06-04
2092401388382873K201214t:slim X2 Insulin Pump with Interoperable TechnologyQFG2020-06-04
3291051388382873K201214t:slim X2 Insulin Pump with Interoperable TechnologyQFG2020-06-04
3309501388382873K201214t:slim X2 Insulin Pump with Interoperable TechnologyQFG2020-06-04
1373801388382873K201214t:slim X2 Insulin Pump with Interoperable TechnologyQFG2020-06-04
3291051162941480K200467Control-IQ TechnologyQJI2020-06-16
2092401162941480K200467Control-IQ TechnologyQJI2020-06-16
2374911162941480K200467Control-IQ TechnologyQJI2020-06-16
1373801162941480K200467Control-IQ TechnologyQJI2020-06-16
2092402071942742K193483Basal-IQ TechnologyQJS2020-02-28
1373802071942742K193483Basal-IQ TechnologyQJS2020-02-28
1373801707798115K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterLZG2016-10-25
2092401707798115K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterLZG2016-10-25
1373801438817755K160056t:slim Insulin Delivery SystemLZG2016-07-25
2092401438817755K160056t:slim Insulin Delivery SystemLZG2016-07-25
1373801910761684K143189t:flex Insulin Delivery SystemLZG2015-01-09
2092401910761684K143189t:flex Insulin Delivery SystemLZG2015-01-09
2092401074695743K141758T:SLIM INSULIN DELIVERY SYSTEMLZG2014-10-31
1373801074695743K141758T:SLIM INSULIN DELIVERY SYSTEMLZG2014-10-31
2092401578790731K133593T:SLIM INSULIN DELIVERY SYSTEMLZG2014-03-24
1373801578790731K133593T:SLIM INSULIN DELIVERY SYSTEMLZG2014-03-24
1373801346835745K122361T:CONNECT DATA MANAGEMENT SYSTEMOUG2013-02-22
2092401346835745K122361T:CONNECT DATA MANAGEMENT SYSTEMOUG2013-02-22
1373801042241112K111210T:SLIM (TM) INSULIN DELIVERY SYSTEMLZG2011-11-09
2092401042241112K111210T:SLIM (TM) INSULIN DELIVERY SYSTEMLZG2011-11-09
2374911042241112K111210T:SLIM (TM) INSULIN DELIVERY SYSTEMLZG2011-11-09
2374911526051250DEN190034Control-IQ TechnologyQJI2019-12-13
2092401526051250DEN190034Control-IQ TechnologyQJI2019-12-13
1373801526051250DEN190034Control-IQ TechnologyQJI2019-12-13
2374911303629943DEN180058t:slim X2 insulin pump with interoperable technologyQFG2019-02-14
2092401303629943DEN180058t:slim X2 insulin pump with interoperable technologyQFG2019-02-14
1373801303629943DEN180058t:slim X2 insulin pump with interoperable technologyQFG2019-02-14
1373801100605184
1373801214994383
2092401591001136
2374911591001136
1373801591001136
3309501591001136
1373801895851510
2374912071942742

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QFG302025-11-06
LZG132016-10-25
QJI102023-11-03
OZO32018-06-21
QJS22020-02-28
OYC22015-09-08
OUG22013-02-22
FPA12025-08-06

PMA#

PMN#

GUDID#

80 records. Showing 1-40. Next