FDA Import Refusal 799-1672114-8/10002/1 — DAEJU MEDITECH ENGINEERING CO., LTD.

DAEJU MEDITECH ENGINEERING CO., LTD. — FEI 3020770009

The FDA refused shipment 799-1672114-8/10002/1 from DAEJU MEDITECH ENGINEERING CO., LTD. (South Korea) on May 14, 2026. The refused product falls under Devices — HIGH INTENSITY FOCUSED ULTRASOUND SYSTEM FOR PERIPHERAL NEURAL TISSUE ABLATION. Cited charges: 118,237,341,508

Refusal Details

Date
May 14, 2026
Country
South Korea
Product Category
Devices
Product Code
84SGN HIGH INTENSITY FOCUSED ULTRASOUND SYSTEM FOR PERIPHERAL NEURAL TISSUE ABLATION
Charges
118,237,341,508

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.