Day

May 11, 2026
Company: Dexcom, Inc. Date of Enforcement Report: 5/11/2026 Class: II PRODUCT: 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...
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Company: Dexcom, Inc. Date of Enforcement Report: 5/11/2026 Class: II PRODUCT 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...
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Company: Technological Medical Advancements LLC Date of Enforcement Report: 5/11/2026 Class: II PRODUCT Diowave Laser System, REF: Diowave 250W Recall Number: Z-2162-2026 REASON: Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local...
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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

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