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Edan Diagnostics

17 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Descript recall (Z-1140-2026)Edan Diagnostics2026-01-22
Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 E recall (Z-1141-2026)Edan Diagnostics2026-01-22
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Descri recall (Z-1142-2026)Edan Diagnostics2026-01-22
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Descr recall (Z-1143-2026)Edan Diagnostics2026-01-22
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3B recall (Z-1144-2026)Edan Diagnostics2026-01-22
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM8 recall (Z-1145-2026)Edan Diagnostics2026-01-22
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, e recall (Z-1146-2026)Edan Diagnostics2026-01-22
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Descript recall (Z-1147-2026)Edan Diagnostics2026-01-22
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product recall (Z-1148-2026)Edan Diagnostics2026-01-22
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Prod recall (Z-1149-2026)Edan Diagnostics2026-01-22
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Pro recall (Z-1150-2026)Edan Diagnostics2026-01-22
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MF recall (Z-1151-2026)Edan Diagnostics2026-01-22
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Descr recall (Z-1152-2026)Edan Diagnostics2026-01-22
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Descr recall (Z-1153-2026)Edan Diagnostics2026-01-22
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Produ recall (Z-1154-2026)Edan Diagnostics2026-01-22
Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product De recall (Z-1155-2026)Edan Diagnostics2026-01-22
EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is recall (Z-1256-2020)Edan Diagnostics2020-02-18

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Every clearance here is in the API, with alerts when new ones post.