Data / Medical devices / South Korea / Mediana Co., Ltd.

Mediana Co., Ltd.: FDA-registered device maker in Wonju-Si, Gangwon-do, South Korea, 9 510(k) clearances

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

Mediana Co., Ltd. is registered with the FDA (registration 3003591740) in Wonju-Si, Gangwon-do, South Korea. It lists 13 device types. The FDA files 9 510(k) clearances under its listings, the newest dated October 9, 2020. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003591740
Address: 132, Donghwagongdan-ro, Munmak-eup, Wonju-Si, Gangwon-do, South Korea, 26365
Owner or operator: MEDIANA CO., LTD. (9048468)
Roles: Contract manufacturer, Manufacturer
First device listed: August 15, 2005
Registered through: 2026
Brand names listed: ARGUS VCM SERIES, AVM-1, AVSM i, AVSM2, BP S510 Colin Press Mate, Body Composition Analyzer, DT-100, Diagnostic Ultrasuond System and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Body Composition, Exempt	PUH	2	Manufacturer	accessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Manufacturer	accessdata.fda.gov
Camera, Television, Endoscopic, Without Audio	FWF	1	Manufacturer	accessdata.fda.gov
Computer, Blood-Pressure	DSK	2	Manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Manufacturer	accessdata.fda.gov
Electrocardiograph	DPS	2	Manufacturer	accessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	QKR	N	Manufacturer	accessdata.fda.gov
Microscope, Surgical, General & Plastic Surgery	FSO	1	Manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Contract manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Manufacturer	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
October 9, 2020	K200434	V20, V20a, AVSM3 SNF	DXN	Substantially Equivalent	Mediana Co., Ltd.	accessdata.fda.gov
December 15, 2017	K170497	V10	DXN	Substantially Equivalent	Mediana Co., Ltd.	accessdata.fda.gov
February 24, 2017	K160358	DT-100	FLL	Substantially Equivalent	Mediana Co., Ltd.	accessdata.fda.gov
November 9, 2011	K112190	PATIENT MONITOR	MHX	Substantially Equivalent	Mediana Co., Ltd.	accessdata.fda.gov
June 8, 2010	K100217	LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30	MHX	Substantially Equivalent	Mediana Co., Ltd.	accessdata.fda.gov
October 22, 2008	K082812	OMRON MODEL HBP-2070 VITAL SIGNS MONITOR	MWI	Substantially Equivalent	Omron Healthcare, Inc.	accessdata.fda.gov
July 2, 2007	K071645	MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S	MWI	Substantially Equivalent	Omron Healthcare, Inc.	accessdata.fda.gov
May 9, 2007	K063690	COLIN PRESS MATE, MODEL BP S510	MHX	Substantially Equivalent	Omron Healthcare, Inc.	accessdata.fda.gov
July 28, 2005	K051375	VITAL SIGNS MONITOR	DXN	Substantially Equivalent	Mediana Co., Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 17, 2021	88166	Class II	Terminated	AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and n	In some cases the equipment fails to power up and/or key or button unresponsive or not working.	accessdata.fda.gov
May 15, 2020	85685	Class II	Terminated	DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (T	Failures were found in the temperature measurement function while in the predict mode.	accessdata.fda.gov

Compare with other makers

Updated October 9, 2020. 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.