FDA.reportPublic FDA data

DEXCO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12262103002790851Dexter-Russell, Inc1N2026-01-01174 CHARLTON RD STURBRIDGE MA US 01566
29162732916273DEXTA CORP.1N2026-01-01957 Enterprise Way NAPA CA US 94558
30047538383004753838DEXCOM, INC.1N2026-01-016340 Sequence Dr SAN DIEGO CA US 92121
30070653583007065358DEXCOWIN CO., LTD.1N2026-01-01901-905, 25, Gasan digital 1-ro Geumcheon-gu Seoul KR 08594
30102232913010223291DEXCOWIN GLOBAL INC.1Y2026-01-01Office # 878 Regus Center 155 Lake Ave., Suite 800 Pasadena CA US 91101
30134351213013435121Dexcom, Inc.1N2026-01-01232 South Dobson Road Mesa AZ US 85202
30153093583015309358DEXIOS SERVICES, LLC.1N2026-01-0110308 Bailey Road Suite 430 Cornelius NC US 28031
30174258683017425868Dexcom, Inc.1Y2026-01-018046 East Ray Road Mesa AZ US 85212
30373265823037326582DEXCOM INTERNATIONAL LIMITED1N2026-01-01Newford Athenry Galway IE H65 F978
00DEXING JINLIN INDUSTRIAL CO.LTD5N2020-04-25Yinlu Industrial Zone, Dexing Shangrao Jiangxi CN 334200
00DEXING XIANGXING WEIYE WEAVING CO., LTD5N2020-04-25Yinlu Gongye Industry Dexing Jiangxi CN 334200
30128549043012854904DEXAM INSTRUMENTS1N2020-04-25Muhallah mughal pura Gohad pur Sialkot Punjab PK 51310

GUDID Contact Samples#

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

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00386270004338Stelo Biosensor - 9500-1741-888-738-3646techsupport@dexcom.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
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
1492351988251054K250687Cocoon Solo (DX-7020s)MUH2025-10-24
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
239221885762539K240902Dexcom G7 Continuous Glucose Monitoring SystemQBJ2024-04-23
3471441885762539K240902Dexcom G7 Continuous Glucose Monitoring SystemQBJ2024-04-23
239221519804588K234070Stelo Glucose Biosensor SystemSAF2024-03-05
3471441519804588K234070Stelo Glucose Biosensor SystemSAF2024-03-05
2035141519804588K234070Stelo 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
239221505965535K191833Dexcom G6 Pro Continuous Glucose Monitoring SystemQII2019-10-07
2035141505965535K191833Dexcom G6 Pro Continuous Glucose Monitoring SystemQII2019-10-07
2035141419219198K182405Dexcom Pro Q Continuous Glucose Monitoring SystemQDL2018-11-02
239221419219198K182405Dexcom 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
1492351774690400K173046Cocoon Portable Handheld X-Ray SystemMUH2017-10-26
2376461481503974K162759KeraStat(R) GelKGN2017-06-02
1492352065742046K143494ADX6000 Portable X-Ray System; iRayA6IZL2015-10-05
1492351848934447K140060DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000AMQB2014-05-13
1492351827872708K134055ADX4000WMUH2014-05-09
1492351636538386K133007DX3000-LMUH2014-04-24
1492351069454816K083532ADX4000-L, DX3000-LMUH2009-03-10
1492351019996825K070811CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000MUH2007-07-05
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
2578091147819573
2388431179030885
2470091350086659
2275391598989639
2578091610433965
2388431660005546
2388431854717031
2388431946433375
386901992157194
386901036194797
1492351100882599
1492351120485004
1492351158907443
386901364838504
386901415516584
2376461481503974
239221551536476
386901845221965
2376461877557880
386901893781806
2035141926165166
239221926165166
386901968398018

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QBJ122025-04-09
MUH62025-10-24
SAF32024-03-05
QII22019-10-07
QDL22018-11-02
QDK22018-10-26
MDS22012-10-05
QRX12025-11-18
KGN12017-06-02
IZL12015-10-05
PJT12015-01-23
PHV12014-08-19
MQB12014-05-13
MDS 12006-03-24

NDC#

Finafta

Dextrum Laboratories Inc.

Benzocaine

Dometuss

Dextrum Laboratories, Inc

Chlorpheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCL

Giltuss Diabetic

Dextrum Laboratories, Inc

Dextromethorphan hydrobromide, Guaifenesin

Giltuss Cough and Cold

Dextrum Laboratories Inc.

Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride

Rompe Pecho CF

Dextrum Laboratories, Inc

Brompheniramine Maleate, Dextromethorphan HBr

Giltuss Allergy Plus

Dextrum Laboratories Inc.

CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

SUPRESS A

Dextrum Laboratories, Inc

Dexbromopheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl

Rycontuss

Dextrum Laboratories, Inc

CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

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#

76 records. Showing 1-40. Next

Applications#

214278

Dexcel Pharma Technologies Ltd.

GUDID#

80 records. Showing 1-40. Next