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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 16 Results
Related Medical Device Recalls
 
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Z-1150-2026 - Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information ... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
Z-1151-2026 - Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applicatio... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
Z-1141-2026 - Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monitors, which are used... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
Z-1140-2026 - Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological param... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
Z-1148-2026 - Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous ... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
Z-1146-2026 - Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can p... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
Z-1147-2026 - Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring ... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
Z-1145-2026 - Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-t... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
Z-1154-2026 - Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiolo... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
Z-1149-2026 - Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous... 2 01/22/2026 FEI # 3009499478
Edan Diagnostics
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