Transcoject GmbH & Co. KG FDA Record

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

Transcoject GmbH & Co. KG has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Transcoject GmbH & Co. KG" is on file.

What these totals cover: FDA records filed under the name "Transcoject GmbH & Co. KG" and its spelling variant "Transcoject Gmbh And Co. Kg". Records filed under related names are not included; see Related names.

Latest 510(k)
Jul 24, 1985

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 Jul 24, 1985.

K-NumberDeviceDate
K851523DISPOSABLE PLASTIC SYRINGESJul 24, 1985

Transcoject GmbH & Co. KG and the FDA: common questions

Has Transcoject GmbH & Co. KG received an FDA warning letter?

No FDA warning letter addressed to the name "Transcoject GmbH & Co. KG" 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 Transcoject GmbH & Co. KG received an FDA Form 483?

FDA has not published a Form 483 for "Transcoject GmbH & Co. KG" 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.