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Zylox Medtech Co., Ltd.

FDA Regulatory Profile

Zylox Medtech Co., Ltd. has 0 FDA recalls, 0 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Oct 22, 2026

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances2Nov 8, 2026File dated Nov 2, 2026Current
Inspections0Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent 510(k) Clearances

K-NumberDeviceDate
K260686Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring CatheterOct 22, 2026
K260416ZYLOX Hippo PTA Balloon Dilatation CatheterSep 21, 2026

FDA data resources

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