Mediana Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
10
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2096-2021Class IIAVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood prMay 17, 2021
Z-2441-2020Class IIDIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to May 15, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K200434V20, V20a, AVSM3 SNFOctober 9, 2020
K170497V10December 15, 2017
K160358DT-100February 24, 2017
K152659V10August 25, 2016
K112190PATIENT MONITORNovember 9, 2011
K110612FM20November 8, 2011
K110630F10June 24, 2011
K100225PULSE OXIMETER MODEL P10February 9, 2011
K100217LUCON M-SERIES PATIENT MONITOR, MODELS M20 AND M30June 8, 2010
K051375VITAL SIGNS MONITORJuly 28, 2005