Medical Device Manufacturer · CN , Shenzhen

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

154 submissions · 154 cleared · Since 2004
154
Total
154
Cleared
0
Denied

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — FDA 510(k) Submissions

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. has submitted 154 FDA 510(k) premarket notifications since 2004, of which 154 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Imaging, Pulsed Doppler, Ultrasonic, Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms), System, Imaging, Pulsed Echo, Ultrasonic, System, Network And Communication, Physiological Monitors, Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) . Use the specialty filter in the sidebar to narrow results.

154 devices
1–25 of 154
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
K253049 · IYN System, Imaging, Pulsed... · Radiology
Feb 2026 142d
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
K251601 · IYN System, Imaging, Pulsed... · Radiology
Dec 2025 190d
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
K251853 · IYN System, Imaging, Pulsed... · Radiology
Nov 2025 143d
ViewMateTM Ultrasound System
K251820 · IYN System, Imaging, Pulsed... · Radiology
Sep 2025 91d
ViewMate? Multi Ultrasound System (VMM-ICE-01); ViewMate? Multi Ultrasound System (VMM-ICE-02)
K251250 · IYN System, Imaging, Pulsed... · Radiology
Sep 2025 135d
SV600, SV800 Ventilator
K243767 · CBK Ventilator, Continuous,... · Anesthesiology
Aug 2025 265d
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)
K251192 · IYN System, Imaging, Pulsed... · Radiology
Aug 2025 127d
BeneVision Central Monitoring System
K242728 · MSX System, Network And... · Cardiovascular
Jul 2025 324d
TE Air Diagnostic Ultrasound System
K250024 · IYN System, Imaging, Pulsed... · Radiology
May 2025 144d
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
K250020 · IYN System, Imaging, Pulsed... · Radiology
May 2025 136d
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);
K250110 · IYN System, Imaging, Pulsed... · Radiology
May 2025 120d
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
K242231 · IYN System, Imaging, Pulsed... · Radiology
Nov 2024 101d
V80 Anesthetic Vaporizer (V80)
K240375 · CAD Vaporizer, Anesthesia,... · Anesthesiology
Oct 2024 267d
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
K241201 · IYN System, Imaging, Pulsed... · Radiology
Sep 2024 139d
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System
K241432 · IYN System, Imaging, Pulsed... · Radiology
Sep 2024 114d
TE Air Diagnostic Ultrasound System
K240906 · IYN System, Imaging, Pulsed... · Radiology
Jul 2024 112d
Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System
K240684 · IYN System, Imaging, Pulsed... · Radiology
Jun 2024 97d
Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System
K240115 · IYN System, Imaging, Pulsed... · Radiology
Apr 2024 97d
TE Air Diagnostic Ultrasound System
K231685 · IYN System, Imaging, Pulsed... · Radiology
Oct 2023 139d
Mindray SV600 Ventilator, Mindray SV800 Ventilator
K220107 · CBK Ventilator, Continuous,... · Anesthesiology
Jun 2023 520d
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System
K230768 · IYN System, Imaging, Pulsed... · Radiology
Jun 2023 81d
Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System
K222928 · IYN System, Imaging, Pulsed... · Radiology
Feb 2023 134d
Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor
K221113 · MWI Monitor, Physiological,... · Cardiovascular
Dec 2022 231d
Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System
K221300 · IYN System, Imaging, Pulsed... · Radiology
Sep 2022 147d
Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System
K221496 · IYN System, Imaging, Pulsed... · Radiology
Sep 2022 129d

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