Data / Medical devices / United States / Medisono, LLC

Medisono, LLC: FDA-registered device maker in Doral, FL, United States, 37 510(k) clearances

Name: Medisono, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medisono, LLC is registered with the FDA (registration 3010390468) in Doral, FL, United States. It lists 29 device types. The FDA files 37 510(k) clearances under its listings, the newest dated July 29, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010390468
Address: 3016 NW 82nd Ave, Doral, FL, United States, 33122
Owner or operator: Medisono, LLC (10044902)
Roles: Repackager or relabeler
First device listed: June 13, 2017
Registered through: 2026
Brand names listed: BLU12+ Patient Monitor MEDISONO Brand Mediblu , BLU15+ Patient Monitor MEDISONO, Blood Pressure Holter System HA5P MEDISONO Brand Mediblu, CART, EMERGENCY, CARDIOPULMONARY, Central Patient Monitor System CMS4 MEDISONO Brand Mediblu, ECG MEDISONO Brand Mediblu ME3, ME6, ME12P, ME15P, FD1 Ultrasonic Pocket Doppler MEDISONO Brand Mediblu, FM02 Fetal Monitor MEDISONO Brand Mediblu, HA3P HOLTER SYSTEM MEDISONO Brand Mediblu and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Repackager or relabeler	accessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	2	Repackager or relabeler	accessdata.fda.gov
Camera, Multi Format, Radiological	LMC	2	Repackager or relabeler	accessdata.fda.gov
Cart, Emergency, Cardiopulmonary (Excluding Equipment)	BZN	1	Repackager or relabeler	accessdata.fda.gov
Colonoscope And Accessories, Flexible/Rigid	FDF	2	Repackager or relabeler	accessdata.fda.gov
Colposcope (And Colpomicroscope)	HEX	2	Repackager or relabeler	accessdata.fda.gov
Computer, Blood-Pressure	DSK	2	Repackager or relabeler	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Repackager or relabeler	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Repackager or relabeler	accessdata.fda.gov
Detector And Alarm, Arrhythmia	DSI	2	Repackager or relabeler	accessdata.fda.gov
Electrocardiograph	DPS	2	Repackager or relabeler	accessdata.fda.gov
Electrocardiograph, Ambulatory (Without Analysis)	MWJ	2	Repackager or relabeler	accessdata.fda.gov
Electrocardiograph, Ambulatory, With Analysis Algorithm	MLO	2	Repackager or relabeler	accessdata.fda.gov
Endoscope, Accessories, Narrow Band Spectrum	NWB	2	Repackager or relabeler	accessdata.fda.gov
Flowmeter, Blood, Cardiovascular	DPW	2	Repackager or relabeler	accessdata.fda.gov
Gastroscope And Accessories, Flexible/Rigid	FDS	2	Repackager or relabeler	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Repackager or relabeler	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Repackager or relabeler	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Repackager or relabeler	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Repackager or relabeler	accessdata.fda.gov
Monitor, St Segment With Alarm	MLD	2	Repackager or relabeler	accessdata.fda.gov
Monitor, Ultrasonic, Fetal	KNG	2	Repackager or relabeler	accessdata.fda.gov
Oximeter	DQA	2	Repackager or relabeler	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Repackager or relabeler	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Repackager or relabeler	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Repackager or relabeler	accessdata.fda.gov
System, Monitoring, Perinatal	HGM	2	Repackager or relabeler	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Repackager or relabeler	accessdata.fda.gov
Transducer, Ultrasonic, Obstetric	HGL	2	Repackager or relabeler	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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 29, 2025	K250179	Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)	MHX	Substantially Equivalent	Edan Instruments, Inc.	accessdata.fda.gov
June 12, 2024	K233266	MEDIBLU ECG SYSTEM	DPS	Substantially Equivalent	Mediblu Medical, LLC	accessdata.fda.gov
March 8, 2024	K233038	Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s	MWI	Substantially Equivalent	Edan Instruments, Inc.	accessdata.fda.gov
February 15, 2024	K231659	MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus)	IYN	Substantially Equivalent	Medisono	accessdata.fda.gov
October 25, 2022	K222365	Leltek Ultrasound Imaging System (Model: LU700 Series)	IYN	Substantially Equivalent	Leltek, Inc.	accessdata.fda.gov
September 15, 2022	K221089	P12 Elite Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
September 13, 2022	K221140	P20 Elite Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
September 8, 2022	K222020	HD-550 Video Endoscope System	NWB	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
April 1, 2022	K211882	HD-550 Video Endoscope System	NWB	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
January 29, 2019	K182648	X5 Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
September 5, 2018	K173921	HD-500 Video Endoscope System	NWB	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
December 5, 2017	K172993	P20 Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
December 1, 2017	K173058	P10 Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
September 21, 2017	K172082	S60 Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
July 12, 2017	K170999	P50 Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
July 11, 2017	K171000	P60 Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
May 19, 2017	K170303	E5 Series Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
May 17, 2017	K170078	Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley	IYN	Substantially Equivalent	Medisono, LLC	accessdata.fda.gov
February 23, 2017	K163688	Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10	IYN	Substantially Equivalent	Medisono, LLC	accessdata.fda.gov
January 3, 2017	K163427	X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
September 14, 2016	K160341	Colposcope System	HEX	Substantially Equivalent	Xuzhou Kernel Medical Equipment Co., Ltd.	accessdata.fda.gov
April 1, 2016	K160258	X5 Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
February 5, 2016	K152427	PC ECG	DPS	Substantially Equivalent	Edan Instruments, Inc.	accessdata.fda.gov
January 27, 2016	K151787	Holter System	DQK	Substantially Equivalent	Edan Instruments, Inc.	accessdata.fda.gov
August 28, 2015	K152164	S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Medical Corp.	accessdata.fda.gov
March 30, 2015	K143695	CENTRAL MONITORING SYSTEM	HGM	Substantially Equivalent	Edan Instruments, Inc.	accessdata.fda.gov
February 6, 2015	K140579	ULTRASONIC POCKET DOPPLER	KNG	Substantially Equivalent	Edan Instruments, Inc.	accessdata.fda.gov
January 29, 2015	K142714	S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System	IYN	Substantially Equivalent	Sonoscape Company Limited	accessdata.fda.gov
June 26, 2014	K141454	SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD	LMC	Substantially Equivalent	Sony Electronics, Inc.	accessdata.fda.gov
February 18, 2014	K131898	A SERIES AND Q SERIES PATIENT MONITORS	MWI	Substantially Equivalent	Guangdong Biolight Meditech Co., Ltd.	accessdata.fda.gov
August 1, 2013	K131305	CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE	IYN	Substantially Equivalent	Chison Medical Imaging Co., Ltd.	accessdata.fda.gov
February 14, 2012	K120144	VITAL SIGNS MONITOR	DXN	Substantially Equivalent	Edan Instruments, Inc.	accessdata.fda.gov
September 30, 2011	K101273	DYNAMIC ECG SYSTEM MODEL TLC5000	MLO	Substantially Equivalent	Contec Medical System Co., Ltd.	accessdata.fda.gov
July 27, 2011	K110156	AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER,	DXN	Substantially Equivalent	Contec Medical System Co., Ltd.	accessdata.fda.gov
January 13, 2011	K102140	FETAL MONITORS, MODELS F2 AND F3	HGM	Substantially Equivalent	Edan Instruments, Inc.	accessdata.fda.gov
February 2, 2010	K092970	GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H	MHX	Substantially Equivalent	General Meditech, Inc.	accessdata.fda.gov
January 7, 2009	K082789	G1B PULSE OXIMETER	DQA	Substantially Equivalent	General Meditech, Inc.	accessdata.fda.gov

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Updated July 29, 2025. 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.