Dexcom, Inc.
Dexcom, Inc. holds FDA 510(k) medical device clearances, first cleared 2014, most recent 2026, with 29 FDA device recalls on record.
Top product codes for Dexcom, Inc.
FDA recalls by Dexcom, Inc.
10 most recent of 29- Z-2574-2026 — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: Dexcom G7 US Retail Sensor/Transmitter 1-pack Component: Dexcom G7 Continuous Glucose Monitoring System
- Z-2164-2026 — 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
- Z-2163-2026 — 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
- Z-2165-2026 — 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
- Z-0318-2026 — Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose Monitoring System
- Z-2450-2025 — Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System
- Z-2448-2025 — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: versions 2.8.0 and earlier Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used of each are the same for each user. The watchOS app cannot be installed independently from the iOS phone app Component: Dexcom G7 CGM iOS App
- Z-2446-2025 — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM Android App SW12299 Component: Dexcom G7 Continuous Glucose Monitoring System
- Z-2447-2025 — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System
- Z-2449-2025 — Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog Number: SW14245 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ Androind CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Dexcom, Inc.
- K262472 — Stelo Glucose Biosensor System
- K260935 — Stelo Glucose Biosensor System
- K261402 — Dexcom G7 Continuous Glucose Monitoring System; Dexcom G7 15 Day Continuous Glucose Monitoring System
- K261359 — Stelo Glucose Biosensor System
- K253737 — Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
- K253710 — Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
- K252818 — Dexcom Smart Basal
- K243214 — Dexcom G7 15 Day Continuous Glucose Monitoring System
- K240902 — Dexcom G7 Continuous Glucose Monitoring System
- K234070 — Stelo Glucose Biosensor System
- K234133 — Dexcom G7 Continuous Glucose Monitoring System
- K231081 — Dexcom G7 Continuous Glucose Monitoring (CGM) System
- K223931 — Dexcom G6 Continuous Glucose Monitoring (CGM) System
- K213919 — Dexcom G7 Continuous Glucose Monitoring System
- K221259 — Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System
- K203089 — Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
- K201328 — Dexcom G6 Continuous Glucose Monitoring (CGM) System
- K200876 — Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System
- K193642 — Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
- K192787 — Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System
- K191833 — Dexcom G6 Pro Continuous Glucose Monitoring System
- K191450 — Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System
- K183206 — Dexcom G6 Continuous Glucose Monitoring System
- K182405 — Dexcom Pro Q Continuous Glucose Monitoring System
- K182041 — Dexcom G6 Glucose Program Continuous Glucose Monitoring System
- DEN170088 — Dexcom G6 Continuous Glucose Monitoring System
- DEN140038 — Dexcom Share Direct Secondary Displays
- DEN140016 — STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE
Data sourced from openFDA. This site is unofficial and independent of the FDA.