Data / Medical devices / China / Shenzhen Mindray Bio-Medical Electronics Co.,LTD

Shenzhen Mindray Bio-Medical Electronics Co.,LTD: FDA-registered device maker in SHENZHEN Guangdong, China, 133 510(k) clearances

Name: Shenzhen Mindray Bio-Medical Electronics Co.,LTD FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shenzhen Mindray Bio-Medical Electronics Co.,LTD is registered with the FDA (registration 3007603826) in SHENZHEN Guangdong, China. It lists 61 device types. The FDA files 133 510(k) clearances under its listings, the newest dated June 25, 2026. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this one Watch Shenzhen Mindray Bio-Medical Electronics Co.,LTD

FDA registration number: 3007603826
Address: Mindray Building,keji 12TH Road South Hi-Tech Industrial Park,nanshan, SHENZHEN Guangdong, China, 518057
Owner or operator: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD (9058402)
Roles: Exporter to the US, Repackager or relabeler, Specification developer
First device listed: February 17, 2008
Registered through: 2026
Brand names listed: A3 ANESTHESIA DELIVERY SYSTEM, A4 Anesthesia System, A5 ANESTHESIA DELIVERY SYSTEM, A5 Anesthesia System, A7 Anesthesia System, A8, A9 Anesthesia System, ACCUTORR 7,VS-900 VITAL SIGNS MONITOR, ACUSON Bonsai Diagnostic Ultrasound System and more

Devices it lists

Device	Product code	Class	Role	Source
Alarm, Blood-Pressure	DSJ	2	Exporter to the US, Specification developer	accessdata.fda.gov
Amplifier And Signal Conditioner, Transducer Signal	DRQ	2	Exporter to the US, Specification developer	accessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Exporter to the US, Specification developer	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Exporter to the US, Specification developer	accessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	NHO	2	Exporter to the US, Specification developer	accessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	CBQ	2	Exporter to the US, Specification developer	accessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	CBS	2	Exporter to the US, Specification developer	accessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	NHQ	2	Exporter to the US, Specification developer	accessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	CBR	2	Exporter to the US, Specification developer	accessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	2	Exporter to the US, Specification developer	accessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	NHP	2	Exporter to the US, Specification developer	accessdata.fda.gov
Burst Suppression Detection Software For Electroencephalograph	ORT	2	Exporter to the US, Specification developer	accessdata.fda.gov
Calibrator For Cell Indices	KRX	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Calibrator For Hemoglobin And Hematocrit Measurement	KRZ	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Calibrator For Platelet Counting	KRY	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Calibrator For Red-Cell And White-Cell Counting	KSA	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Computer, Blood-Pressure	DSK	2	Exporter to the US, Specification developer	accessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-Function	DXG	2	Exporter to the US, Specification developer	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Specification developer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Exporter to the US, Specification developer	accessdata.fda.gov
Continuous, Minimal Ventilatory Support, Facility Use Ventilator	MNT	2	Specification developer	accessdata.fda.gov
Counter, Differential Cell	GKZ	2	Exporter to the US, Specification developer	accessdata.fda.gov
Detector And Alarm, Arrhythmia	DSI	2	Exporter to the US, Specification developer	accessdata.fda.gov
Detergent	JCB	1	Exporter to the US, Specification developer	accessdata.fda.gov
Device, Monitoring, Intracranial Pressure	GWM	2	Specification developer	accessdata.fda.gov
Diluent, Blood Cell	GIF	1	Exporter to the US, Specification developer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Exporter to the US, Specification developer	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Exporter to the US, Specification developer	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Exporter to the US, Specification developer	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Exporter to the US, Specification developer	accessdata.fda.gov
Gas-Machine, Anesthesia	BSZ	2	Exporter to the US, Specification developer	accessdata.fda.gov
Hexokinase, Glucose	CFR	2	Exporter to the US, Specification developer	accessdata.fda.gov
Index-Generating Electroencephalograph Software	OLW	2	Exporter to the US, Specification developer	accessdata.fda.gov
Mixture, Hematology Quality Control	JPK	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Exporter to the US, Specification developer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Exporter to the US, Specification developer	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Exporter to the US, Specification developer	accessdata.fda.gov
Monitor, St Segment	MLC	2	Exporter to the US, Specification developer	accessdata.fda.gov
Monitor, St Segment With Alarm	MLD	2	Exporter to the US, Specification developer	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Exporter to the US, Specification developer	accessdata.fda.gov
Oximeter	DQA	2	Exporter to the US, Specification developer	accessdata.fda.gov
Oximeter, Ear	DPZ	2	Specification developer	accessdata.fda.gov
Oximeter, Tissue Saturation	MUD	2	Exporter to the US, Specification developer	accessdata.fda.gov
Plethysmograph, Impedance	DSB	2	Exporter to the US, Specification developer	accessdata.fda.gov
Products, Red-Cell Lysing Products	GGK	1	Exporter to the US, Specification developer	accessdata.fda.gov
Reduced- Montage Standard Electroencephalograph	OMC	2	Exporter to the US, Specification developer	accessdata.fda.gov
Regulator, Vacuum	KDP	2	Exporter to the US, Specification developer	accessdata.fda.gov
Spirometer, Monitoring (W/Wo Alarm)	BZK	2	Exporter to the US, Specification developer	accessdata.fda.gov
Stimulator, Nerve, Peripheral, Electric	KOI	2	Exporter to the US, Specification developer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Exporter to the US, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Exporter to the US, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Exporter to the US, Specification developer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Exporter to the US, Specification developer	accessdata.fda.gov
System, Network And Communication, Physiological Monitors	MSX	2	Exporter to the US, Specification developer	accessdata.fda.gov
Tester, Electrode, Surface, Electrocardiographic	KRC	2	Exporter to the US, Specification developer	accessdata.fda.gov
Transducer, Blood-Pressure, Extravascular	DRS	2	Exporter to the US, Specification developer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Exporter to the US, Specification developer	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Exporter to the US, Specification developer	accessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea Nitrogen	CDQ	2	Exporter to the US, Specification developer	accessdata.fda.gov
Vaporizer, Anesthesia, Non-Heated	CAD	2	Exporter to the US, Repackager or relabeler, Specification developer	accessdata.fda.gov
Ventilator, Continuous, Facility Use	CBK	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 133.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 25, 2026	K253330	A5 Anesthesia System (A5); A7 Anesthesia System (A7)	BSZ	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
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 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
May 11, 2026	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	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
April 16, 2026	K253170	uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
April 6, 2026	K252182	SV70 Ventilator (SV70)	MNT	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
February 11, 2026	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	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
December 3, 2025	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	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
November 7, 2025	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	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
September 12, 2025	K251820	ViewMateTM Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
September 5, 2025	K251250	ViewMate Multi Ultrasound System (VMM-ICE-01); ViewMate Multi Ultrasound System (VMM-ICE-02)	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
August 28, 2025	K243767	SV600, SV800 Ventilator	CBK	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
August 22, 2025	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	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
July 31, 2025	K242728	BeneVision Central Monitoring System	MSX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
May 30, 2025	K250024	TE Air Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
May 19, 2025	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	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
May 16, 2025	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	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
November 8, 2024	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	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
October 31, 2024	K240375	V80 Anesthetic Vaporizer (V80)	CAD	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
September 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/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	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
September 12, 2024	K241432	MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
July 23, 2024	K240906	TE Air Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
June 17, 2024	K240684	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	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
April 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 I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
October 26, 2023	K231685	TE Air Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
June 16, 2023	K220107	Mindray SV600 Ventilator, Mindray SV800 Ventilator	CBK	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
June 9, 2023	K230768	M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
February 7, 2023	K222928	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	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
December 15, 2022	K221267	VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor	MWI	Substantially Equivalent	Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.	accessdata.fda.gov
December 2, 2022	K221113	Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor	MWI	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
November 9, 2022	K222754	ViewMate Multi Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.	accessdata.fda.gov
September 29, 2022	K221496	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	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
September 29, 2022	K221300	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	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
July 12, 2022	K213799	N Series Patient Monitors	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
March 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 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
March 4, 2022	K220051	TE Air Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
November 16, 2021	K212265	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 System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
November 5, 2021	K212900	MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
October 5, 2021	K211475	Vital Signs Monitors	MWI	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
July 1, 2021	K211337	DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
June 10, 2021	K210699	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 System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
June 10, 2021	K210416	M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
April 8, 2021	K202785	Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.	accessdata.fda.gov
March 26, 2021	K201957	A8, A9 Anesthesia System	BSZ	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
March 23, 2021	K203391	TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
January 7, 2021	K202405	BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
November 9, 2020	K201990	DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
August 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 System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
July 24, 2020	K200643	Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
June 8, 2020	K200015	ePM Series Patient monitors	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
May 28, 2020	K200979	DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
May 21, 2020	K193391	BeneVision Central Monitoring System	MSX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
May 7, 2020	K192972	Patient Monitor	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
April 9, 2020	K200001	MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
April 8, 2020	K200411	Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
April 2, 2020	K200251	Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
December 19, 2019	K192410	ZS3 and z.one pro Ultrasound Systems	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
December 13, 2019	K192152	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
October 31, 2019	K191769	ePM Series Patient monitors	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
July 10, 2019	K190011	Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
April 9, 2019	K183660	DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
April 4, 2019	K183377	DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
March 27, 2019	K182821	Accutorr 7/VS-900/VS-900c Vital Signs Monitor	MWI	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
March 13, 2019	K183238	BeneVision Central Monitoring System	MSX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
March 8, 2019	K190206	DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
January 10, 2019	K182636	DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
January 9, 2019	K181637	DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
December 10, 2018	K182075	BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
November 14, 2018	K182603	Z6 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
October 24, 2018	K180788	Gas Module 3	BZK	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
July 30, 2018	K180912	TE7/TE5 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
January 12, 2018	K171311	A5 Anesthesia System	BSZ	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
January 12, 2018	K171292	A7 Anesthesia System	BSZ	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
January 8, 2018	K173471	DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
December 13, 2017	K173369	DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.	accessdata.fda.gov
November 15, 2017	K171901	uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
October 25, 2017	K172970	M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
October 18, 2017	K171579	M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
September 21, 2017	K171891	ZS3 Ultrasound System, z.one pro Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
September 12, 2017	K171233	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.	accessdata.fda.gov
August 23, 2017	K170876	Passport Series Patient Monitors(Passport 12m, Passport 17m)	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
August 2, 2017	K170712	Accutorr 7/VS-900 Vital Signs Monitor	MWI	Substantially Equivalent	Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.	accessdata.fda.gov
July 10, 2017	K171034	M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
April 20, 2017	K163690	DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
April 20, 2017	K162607	BeneVision Central Monitoring System	MSX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
March 23, 2017	K170277	DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
December 15, 2016	K162845	DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
September 6, 2016	K162267	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
September 1, 2016	K160606	BC-5D Hematology Control	JPK	Substantially Equivalent	R&D Systems, Inc.	accessdata.fda.gov
September 1, 2016	K160429	BC-5390 Auto Hematology Analyzer	GKZ	Substantially Equivalent	Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
July 13, 2016	K161525	TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
June 9, 2016	K160370	BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer	JGS	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
March 3, 2016	K153448	Passport Series Patient Monitors (Including Passport 8, Passport 12)	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
February 18, 2016	K152902	Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
October 21, 2015	K152763	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
September 2, 2015	K150082	Panorama Patient Monitoring Network	MHX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
August 21, 2015	K143348	BC-3600 Auto Hematology Analyzer	GKZ	Substantially Equivalent	Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
July 6, 2015	K150632	Hypervisor IX Monitoring System	MSX	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
June 30, 2015	K150167	V60 Anesthetic Vaporizer	CAD	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
June 12, 2015	K150080	DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
May 15, 2015	K151175	ZONARE ZS3 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Zonare Medical Systems, Inc.	accessdata.fda.gov

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Updated June 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.