| Z-1148-2026 | Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Descrip | October 24, 2025 |
| Z-1153-2026 | Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: | October 24, 2025 |
| Z-1141-2026 | Class II | Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, | October 24, 2025 |
| Z-1145-2026 | Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Produ | October 24, 2025 |
| Z-1152-2026 | Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: | October 24, 2025 |
| Z-1140-2026 | Class II | Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: Th | October 24, 2025 |
| Z-1144-2026 | Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s | October 24, 2025 |
| Z-1149-2026 | Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Des | October 24, 2025 |
| Z-1142-2026 | Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: | October 24, 2025 |
| Z-1146-2026 | Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 | October 24, 2025 |
| Z-1147-2026 | Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: Th | October 24, 2025 |
| Z-1154-2026 | Class II | Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Desc | October 24, 2025 |
| Z-1155-2026 | Class II | Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Descripti | October 24, 2025 |
| Z-1150-2026 | Class II | Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product De | October 24, 2025 |
| Z-1143-2026 | Class II | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: | October 24, 2025 |
| Z-1151-2026 | Class II | Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Li | October 24, 2025 |
| Z-1256-2020 | Class II | EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended t | November 17, 2017 |
| Z-2388-2016 | Class II | EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patie | June 23, 2016 |