Dornier Medtech Laser GmbH FDA Record

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

  • Latest inspection NAI · Jul 20, 2017
  • No warning letters matched by name
Inspections 2 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Dornier Medtech Laser GmbH has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Dornier Medtech Laser GmbH" is on file.

What these totals cover: FDA records filed under the name "Dornier Medtech Laser GmbH" and its spelling variant "Dornier Medtech Laser".

Latest inspection
Jul 20, 2017 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

2 inspections from Jul 31, 2014 to Jul 20, 2017.

DateSiteProductClassificationFEI
Jul 20, 2017Wesling, GermanyDevicesNo Action Indicated (NAI)3002807538
Jul 31, 2014Wesling, GermanyDevicesNo Action Indicated (NAI)3002807538
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3002807538Wesling, Germany2Jul 20, 2017

Dornier Medtech Laser GmbH and the FDA: common questions

Has Dornier Medtech Laser GmbH received an FDA warning letter?

No FDA warning letter addressed to the name "Dornier Medtech Laser GmbH" 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 Dornier Medtech Laser GmbH received an FDA Form 483?

FDA has not published a Form 483 for "Dornier Medtech Laser GmbH" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Dornier Medtech Laser GmbH?

The most recent FDA inspection on file ended Jul 20, 2017 at Wesling, Germany and was classified NAI. FDA has 2 inspections of Dornier Medtech Laser GmbH on file.

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