510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Mediana Co., Ltd.

Wonju-Si, Gangwon-do, KR

MEDIANA CO., LTD. appears in FDA device records in Wonju-Si, Gangwon-do, KR. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
10
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 10 510(k) clearances for Mediana Co., Ltd. between 2005 and 2020. The busiest year on record is 2011, with 4. The most recent is 2020, with 1.

Clearances by year, as a table
510(k) clearance decisions for Mediana Co., Ltd., by decision year
YearClearances
20051
20101
20114
20161
20172
20201
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K200434V20, V20a, AVSM3 SNFDXNSubstantially Equivalent
K170497V10DXNSubstantially Equivalent
K160358DT-100FLLSubstantially Equivalent
K152659V10DXNSubstantially Equivalent
K112190PATIENT MONITORMHXSubstantially Equivalent
K110612FM20HGMSubstantially Equivalent
K110630F10KNGSubstantially Equivalent
K100225PULSE OXIMETER MODEL P10DQASubstantially Equivalent
K100217LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30MHXSubstantially Equivalent
K051375VITAL SIGNS MONITORDXNSubstantially Equivalent

Registered establishments

FDA registered establishments for Mediana Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30035917403003591740MEDIANA CO., LTD.132, Donghwagongdan-ro, Munmak-eup, Wonju-Si, Gangwon-do 26365 KR2026and 3 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2096-2021AVSM3 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 neonatal patients in all areas of a hospital and hospital-type facilities.In some cases the equipment fails to power up and/or key or button unresponsive or not working.Class IITerminated
Z-2441-2020DIRECT 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 (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.Failures were found in the temperature measurement function while in the predict mode.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain