Shenzhen Mindray Bio-Medical Electronics Co., Ltd. FDA Approvals

0 new drug approvals and 43 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
A5 Anesthesia System (A5); A7 Anesthesia System (A7)510(k)Jun 25, 2026Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jun 25, 2026
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)510(k)May 20, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 20, 2026
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);Diagnos510(k)May 11, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 11, 2026
uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors510(k)Apr 16, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 16, 2026
SV70 Ventilator (SV70)510(k)Apr 6, 2026Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Apr 6, 2026
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 System510(k)Feb 11, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 11, 2026
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem510(k)Dec 3, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 3, 2025
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 System510(k)Nov 7, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 7, 2025
ViewMateTM Ultrasound System510(k)Sep 12, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 12, 2025
ViewMate Multi Ultrasound System (VMM-ICE-01); ViewMate Multi Ultrasound System (VMM-ICE-02)510(k)Sep 5, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 5, 2025
SV600, SV800 Ventilator510(k)Aug 28, 2025Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Aug 28, 2025
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)510(k)Aug 22, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 22, 2025
BeneVision Central Monitoring System510(k)Jul 31, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 31, 2025
TE Air Diagnostic Ultrasound System510(k)May 30, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 30, 2025
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); Diagnost510(k)May 19, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 19, 2025
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);510(k)May 16, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 16, 2025
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 System510(k)Nov 8, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 8, 2024
V80 Anesthetic Vaporizer (V80)510(k)Oct 31, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Oct 31, 2024
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 System510(k)Sep 16, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 16, 2024
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System510(k)Sep 12, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 12, 2024
TE Air Diagnostic Ultrasound System510(k)Jul 23, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 23, 2024
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 System510(k)Jun 17, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 17, 2024
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 System510(k)Apr 22, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 22, 2024
TE Air Diagnostic Ultrasound System510(k)Oct 26, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 26, 2023
Mindray SV600 Ventilator, Mindray SV800 Ventilator510(k)Jun 16, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jun 16, 2023
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System510(k)Jun 9, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 9, 2023
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 System510(k)Feb 7, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 7, 2023
Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor510(k)Dec 2, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 2, 2022
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 System510(k)Sep 29, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 29, 2022
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 System510(k)Sep 29, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 29, 2022
N Series Patient Monitors510(k)Jul 12, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 12, 2022
BeneVision Central Monitoring System510(k)Jun 1, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 1, 2022
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System510(k)Mar 25, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 25, 2022
TE Air Diagnostic Ultrasound System510(k)Mar 4, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 4, 2022
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System510(k)Nov 16, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 16, 2021
MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System510(k)Nov 5, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 5, 2021
Vital Signs Monitors510(k)Oct 5, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 5, 2021
DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System510(k)Jul 1, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 1, 2021
M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System510(k)Jun 10, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 10, 2021
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 Diagnostic Ultrasound System510(k)Jun 10, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 10, 2021
A8, A9 Anesthesia System510(k)Mar 26, 2021Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Mar 26, 2021
TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System510(k)Mar 23, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 23, 2021
BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1510(k)Jan 7, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 7, 2021

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