12 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System
FDA Enforcement
Class II
·Ongoing·Dexcom, Inc.·May 20, 2026
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System
FDA Enforcement
Class II
·Ongoing·Dexcom, Inc.·May 20, 2026
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used are the same for each user. The watchOS app cannot be installed independently from the iOS phone app. Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System
FDA Enforcement
Class II
·Ongoing·Dexcom, Inc.·May 20, 2026
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
FDA Enforcement
Class II
·Ongoing·Dexcom, Inc.·June 11, 2025
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001
FDA Enforcement
Class II
·Ongoing·Dexcom, Inc.·February 26, 2025
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001
FDA Enforcement
Class II
·Ongoing·Dexcom, Inc.·February 26, 2025
Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
FDA Enforcement
Class II
·Ongoing·Dexcom, Inc.·February 26, 2025
Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804
FDA Enforcement
Class II
·Terminated·Dexcom Inc·February 19, 2020
Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.
FDA Enforcement
Class II
·Terminated·Dexcom Inc·April 1, 2020
Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.
FDA Enforcement
Class II
·Terminated·Dexcom Inc·February 12, 2020
Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.
FDA Enforcement
Class II
·Terminated·Dexcom Inc·April 1, 2020
Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.
FDA Enforcement
Class II
·Terminated·Dexcom Inc·April 1, 2020