fda
22 records
FDA Recall: Dexcom, Inc. — Class I
20250910
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 o | Product: Brand Name: Dexcom G7 Continuous Gluco...
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FDA Device Recall: Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom
2025-11-05
Class I — A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or...
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FDA Device Recall: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom
2025-09-10
Class I — The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System us...
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FDA Device Recall: Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexc
2025-09-10
Class I — The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System us...
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FDA Device Recall: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom
2025-09-10
Class I — The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System us...
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FDA Device Recall: Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexc
2025-09-10
Class I — The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System us...
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FDA Device Recall: Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (
2025-06-25
Class I — Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A mi...
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FDA Device Recall: Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (
2025-06-25
Class I — Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A mi...
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FDA Device Recall: Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 C
2025-06-11
Class II — A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user i...
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FDA Device Recall: Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001
2025-02-26
Class II — Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a rece...
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FDA Device Recall: Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, S
2025-02-26
Class II — Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a rece...
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FDA Recall: Dexcom Inc — Class II
20200401
The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Co | Product: Dexcom G6 Continuous Glucose Monitorin...
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FDA Device Recall: Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continu
2020-04-01
Class II — The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.
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FDA Device Recall: Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINU
2020-04-01
Class II — The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.
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FDA Device Recall: Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continu
2020-04-01
Class II — The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.
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FDA Recall: Dexcom Inc — Class I
20160420
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. | Product: Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg...
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FDA Recall: Dexcom Inc — Class I
20160420
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. | Product: Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL...
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FDA Device Recall: Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiv
2016-04-20
Class I — Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
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FDA Device Recall: Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver
2016-04-20
Class I — Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
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FDA Device Recall: Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Bla
2016-04-20
Class I — Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
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FDA Device Recall: Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black
2016-04-20
Class I — Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
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FDA Device Recall: Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT2260
2016-04-20
Class I — Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
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lobbying
5 records
Lobbying Firm: DEXCOM, INC.
Registered lobbying firm — San Diego, CA — Medical Device manufacturing
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Lobbying Client: DEXCOM, INC.
Lobbied by SQUIRE PATTON BOGGS — DexCom pioneers technologies for monitoring of glucose in people with diabetes.
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Lobbying Client: DEXCOM
Lobbied by CONTINENTAL STRATEGY, LLC — Healthcare company that develops, manufactures, produces, and distributes CGMs.
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nppes
1 records
ny_corps
1 records
NY Corp: DEXCOM, INC.
2021-03-08
FOREIGN BUSINESS CORPORATION | County: Albany | Jurisdiction: Delaware
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SEC EDGAR
1 records
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