MEDIANA CO., LTD.
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
- Inspections (1)
Devices registered here (1)
- System, Imaging, Pulsed Doppler, UltrasonicProduct code IYN (opens in a new tab) · Class II · Radiology · 21 CFR 892.1550
Recalls & enforcement
- Class IITerminated2021-05-17In some cases the equipment fails to power up and/or key or button unresponsive or not working.
- Class IITerminated2020-05-15Failures were found in the temperature measurement function while in the predict mode.
FDA inspections (1)
- VAI2018-09-06Voluntary Action Indicated · Compliance: Devices
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “MEDIANA CO., LTD. (FEI 3003591740) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003591740-mediana-co-ltd/
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