Company · CN
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2026. Name variants (Inc, Corp, punctuation) are merged.
162510(k) clearances (9 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 85 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 23 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 11 |
| MSX | System, Network And Communication, Physiological Monitors | 7 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 7 |
| BSZ | Gas-Machine, Anesthesia | 6 |
| ITX | Transducer, Ultrasonic, Diagnostic | 6 |
| DQA | Oximeter | 4 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 2 |
| CBK | Ventilator, Continuous, Facility Use | 2 |
| CFR | Hexokinase, Glucose | 2 |
| GKZ | Counter, Differential Cell | 2 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 |
| MNT | Continuous, Minimal Ventilatory Support, Facility Use Ventilator | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2026 | K261585 | Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound System (Nuewa Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Oct 8, 2026 | K261617 | Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic Ultrasound System (R Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Jun 25, 2026 | K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7) Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | BSZ |
| May 20, 2026 | 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 1 Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | MHX |
| May 11, 2026 | K260846 | Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ul Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Apr 16, 2026 | K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | MHX |
| Apr 6, 2026 | K252182 | SV70 Ventilator (SV70) Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | MNT |
| Feb 11, 2026 | K253049 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Reso Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Dec 3, 2025 | K251601 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibro Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Nov 7, 2025 | K251853 | Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Sep 12, 2025 | K251820 | ViewMateTM Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Sep 5, 2025 | K251250 | ViewMate Multi Ultrasound System (VMM-ICE-01); ViewMate Multi Ultrasound System (VMM-ICE-02) Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Aug 28, 2025 | K243767 | SV600, SV800 Ventilator Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | CBK |
| Aug 22, 2025 | K251192 | Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnosti Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Jul 31, 2025 | K242728 | BeneVision Central Monitoring System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | MSX |
| May 30, 2025 | K250024 | TE Air Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| May 19, 2025 | K250020 | Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| May 16, 2025 | K250110 | Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Nov 8, 2024 | K242231 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Reso Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Oct 31, 2024 | K240375 | V80 Anesthetic Vaporizer (V80) Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | CAD |
| Sep 16, 2024 | K241201 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/A Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Sep 12, 2024 | K241432 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Jul 23, 2024 | K240906 | TE Air Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Jun 17, 2024 | K240684 | Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imag Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Apr 22, 2024 | K240115 | Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Oct 26, 2023 | K231685 | TE Air Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Jun 16, 2023 | K220107 | Mindray SV600 Ventilator, Mindray SV800 Ventilator Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | CBK |
| Jun 9, 2023 | K230768 | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Feb 7, 2023 | K222928 | Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ N Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Dec 2, 2022 | K221113 | Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | MWI |
| Sep 29, 2022 | K221496 | Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Sep 29, 2022 | K221300 | Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Con Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Jul 12, 2022 | K213799 | N Series Patient Monitors Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | MHX |
| Jun 1, 2022 | K220058 | BeneVision Central Monitoring System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | MSX |
| Mar 25, 2022 | K220242 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Mar 4, 2022 | K220051 | TE Air Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Nov 16, 2021 | K212265 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 E Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Nov 5, 2021 | K212900 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Oct 5, 2021 | K211475 | Vital Signs Monitors Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | MWI |
| Jul 1, 2021 | K211337 | DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Jun 10, 2021 | K210699 | Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imag Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Jun 10, 2021 | K210416 | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Mar 26, 2021 | K201957 | A8, A9 Anesthesia System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | BSZ |
| Mar 23, 2021 | K203391 | TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Jan 7, 2021 | K202405 | BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1 Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | MHX |
| Nov 9, 2020 | K201990 | DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Aug 21, 2020 | K201693 | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Jul 24, 2020 | K200643 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
| Jun 8, 2020 | K200015 | ePM Series Patient monitors Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | MHX |
| May 28, 2020 | K200979 | DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN | IYN |
Newest 50 of 162.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||