FDA import alert status
Kyungwon Medical Co., Ltd.
Korea (The Republic Of) · appears on 2 FDA import alerts
2
Red-list alerts
0
Green-list alerts
Korea (The Republic Of)
Country
01/27/2016
Last entry seen
What this means
As published on the official FDA import alert list, this firm appears on 2 red lists. A red-list firm is subject to Detention Without Physical Examination (DWPE): FDA can detain its shipments at the border automatically, without sampling. The burden shifts to the importer to prove the goods are not violative.
Import alert status changes over time. Import Alert Radar re-checks the official FDA source every day; the entries below reflect the latest refresh (2026-07-21 UTC).
Do you buy from Kyungwon Medical Co., Ltd.?
Put this supplier on watch: we re-check the official FDA import alert list daily and email you the day Kyungwon Medical Co., Ltd. is added to a red list — or removed from one — so a detained shipment never catches you by surprise.
Red-list entries
- Import Alert 89-04RED · 01/07/2013
Detention Without Physical Examination of Devices from Firms that Have not met Device Quality System Requirements
- Import Alert 89-08RED · 01/27/2016
Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)
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