Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
FDA 510(k) & PMA Approved Devices — 88 products
Total Devices88
Categories10
Latest FDA decision2026-06-25
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7) | BSZ | 2026-06-25 | View |
| 510(k) | K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC) | MHX | 2026-05-20 | View |
| 510(k) | K260846 | Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos | IYN | 2026-05-11 | View |
| 510(k) | K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors | MHX | 2026-04-16 | View |
| 510(k) | K252182 | SV70 Ventilator (SV70) | MNT | 2026-04-06 | View |
| 510(k) | K253049 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System | IYN | 2026-02-11 | View |
| 510(k) | K251601 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem | IYN | 2025-12-03 | View |
| 510(k) | K251853 | Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System | IYN | 2025-11-07 | View |
| 510(k) | K251820 | ViewMateTM Ultrasound System | IYN | 2025-09-12 | View |
| 510(k) | K251250 | ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02) | IYN | 2025-09-05 | View |
| 510(k) | K243767 | SV600, SV800 Ventilator | CBK | 2025-08-28 | View |
| 510(k) | K251192 | Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnostic Ultrasound System (Zeus); Diagnostic Ultrasound System (ME7); Diagnostic Ultrasound System (Anesus ME7); Diagnostic Ultrasound System (Anesus ME7T); Diagnostic Ultrasound System (MX7P); Diagnostic Ultrasound System (MX7W); Diagnostic Ultrasound System (MX8); Diagnostic Ultrasound System (MX8T); Diagnostic Ultrasound System (Vaus8); Diagnostic Ultrasound System (ME8) | IYN | 2025-08-22 | View |
| 510(k) | K242728 | BeneVision Central Monitoring System | MSX | 2025-07-31 | View |
| 510(k) | K250024 | TE Air Diagnostic Ultrasound System | IYN | 2025-05-30 | View |
| 510(k) | K250020 | Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost | IYN | 2025-05-19 | View |
| 510(k) | K250110 | Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6); | IYN | 2025-05-16 | View |
| 510(k) | K242231 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System | IYN | 2024-11-08 | View |
| 510(k) | K240375 | V80 Anesthetic Vaporizer (V80) | CAD | 2024-10-31 | View |
| 510(k) | K241201 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System | IYN | 2024-09-16 | View |
| 510(k) | K241432 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System | IYN | 2024-09-12 | View |
No matching devices.
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