FDA.report

DEXCOM, INC.

Matched from indexed company URL: Dexcom, Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30047538383004753838DEXCOM, INC.1N2026-01-016340 Sequence Dr SAN DIEGO CA US 92121
30134351213013435121Dexcom, Inc.1N2026-01-01232 South Dobson Road Mesa AZ US 85202
30174258683017425868Dexcom, Inc.1Y2026-01-018046 East Ray Road Mesa AZ US 85212
30373265823037326582DEXCOM INTERNATIONAL LIMITED1N2026-01-01Newford Athenry Galway IE H65 F978

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
00386270004574Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System - G7 GSS 15-day Sensor1-888-738-3646techsupport@dexcom.com
00386270004727Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System - G7 15 Day US Sample Pack1-888-738-3646techsupport@dexcom.com
00386270004734Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System - G7 15 Day US Retail Gov Sensor 1pk1-888-738-3646techsupport@dexcom.com
00386270004741Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System - G7 15 Day US Medicare Sensor 1pk1-888-738-3646techsupport@dexcom.com
00386270004758Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System - G7 15 Day US DME 1 Pack1-888-738-3646techsupport@dexcom.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
239221949011218P120005DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEMMDS2012-10-05
2035141949011218P120005DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEMMDS2012-10-05
239222040492510P050012DEXCOM STS CONTINOUS MONITORSMDS2006-03-24
239221883305833K252818Dexcom Smart BasalQRX2025-11-18
3471441745741017K243214Dexcom G7 15 Day Continuous Glucose Monitoring SystemQBJ2025-04-09
2035141745741017K243214Dexcom G7 15 Day Continuous Glucose Monitoring SystemQBJ2025-04-09
239221745741017K243214Dexcom G7 15 Day Continuous Glucose Monitoring SystemQBJ2025-04-09
2035141885762539K240902Dexcom G7 Continuous Glucose Monitoring SystemQBJ2024-04-23
3471441885762539K240902Dexcom G7 Continuous Glucose Monitoring SystemQBJ2024-04-23
239221885762539K240902Dexcom G7 Continuous Glucose Monitoring SystemQBJ2024-04-23
3471441519804588K234070Stelo Glucose Biosensor SystemSAF2024-03-05
2035141519804588K234070Stelo Glucose Biosensor SystemSAF2024-03-05
239221519804588K234070Stelo Glucose Biosensor SystemSAF2024-03-05
239221957496497K223931Dexcom G6 Continuous Glucose Monitoring (CGM) SystemQBJ2023-01-11
2035141957496497K223931Dexcom G6 Continuous Glucose Monitoring (CGM) SystemQBJ2023-01-11
239221086177006K221259Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) SystemQBJ2022-07-29
2035141086177006K221259Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) SystemQBJ2022-07-29
2035141505965535K191833Dexcom G6 Pro Continuous Glucose Monitoring SystemQII2019-10-07
239221505965535K191833Dexcom G6 Pro Continuous Glucose Monitoring SystemQII2019-10-07
239221419219198K182405Dexcom Pro Q Continuous Glucose Monitoring SystemQDL2018-11-02
2035141419219198K182405Dexcom Pro Q Continuous Glucose Monitoring SystemQDL2018-11-02
239221923939341K182041Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemQDK2018-10-26
2035141923939341K182041Dexcom G6 Glucose Program Continuous Glucose Monitoring SystemQDK2018-10-26
2035141744225550DEN170088Dexcom G6 Continuous Glucose Monitoring SystemQBJ2018-03-27
239221744225550DEN170088Dexcom G6 Continuous Glucose Monitoring SystemQBJ2018-03-27
239221739918133DEN140038Dexcom Share Direct Secondary DisplaysPJT2015-01-23
239221868061062DEN140016STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWAREPHV2014-08-19
239221551536476
2035141926165166
239221926165166

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
QBJ122025-04-09
SAF32024-03-05
QII22019-10-07
QDL22018-11-02
QDK22018-10-26
MDS22012-10-05
QRX12025-11-18
PJT12015-01-23
PHV12014-08-19
MDS 12006-03-24

PMA

DEXCOM G5 Mobile Continuous Glucose Monitoring System

2023-01-12

DEXCOM, INC.6340 Sequence Drsan Diego, CA 92121 PMA NumberP120005 Supplement NumberS090 Date Received10/14/2022 Decision Date01/12/2023 Product Code MDS  Advisory Committee Clinical Chemistry Supplement Typenormal 180 Day Track No User Fee Supplement Reason...

132 records. Showing 1-40. Next

PMN

GUDID

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