Alliedstar Medical Equipment Co., Ltd. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • No warning letters matched by name
Inspections 0 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 1 Latest Oct 14, 2026

Alliedstar Medical Equipment Co., Ltd. has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Alliedstar Medical Equipment Co., Ltd." is on file.

What these totals cover: FDA records filed under the name "Alliedstar Medical Equipment Co., Ltd." and its spelling variant "Alliedstar Medical Equipment Co".

Latest 510(k)
Oct 14, 2026

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances1Nov 8, 2026File dated Nov 2, 2026Current
Inspections0Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent 510(k) clearances

1 510(k) clearance on Oct 14, 2026.

K-NumberDeviceDate
K262042Sterilization Cassette (CASS-1)Oct 14, 2026

Alliedstar Medical Equipment Co., Ltd. and the FDA: common questions

Has Alliedstar Medical Equipment Co., Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Alliedstar Medical Equipment Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Alliedstar Medical Equipment Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Alliedstar Medical Equipment Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

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