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Medinvents

FDA Regulatory Profile

Medinvents has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Medinvents".

Latest inspection: Jan 24, 2013 · VAI
Latest 510(k): Apr 11, 2008

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	2	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	1	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

Recent FDA inspections

1 inspection on Jan 24, 2013.

Date	Site	Product	Classification	FEI
Jan 24, 2013	Hasselt, Belgium	Devices	Voluntary Action Indicated (VAI)	3007513241

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Medinvents: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jun 6, 2013.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3007513241	Hasselt, Belgium	1	Jan 24, 2013

Recent 510(k) clearances

2 510(k) clearances from Jul 13, 2006 to Apr 11, 2008.

K-Number	Device	Date
K080095	CORAMATE/SPIROTOME SYSTEM	Apr 11, 2008
K060384	CORAMATE/SPIROTOME SYSTEM	Jul 13, 2006

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