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Alseal

FDA Regulatory Profile

Alseal has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 1 compliance action on record.

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

Latest inspection: Jun 9, 2016 · OAI
Latest 510(k): Aug 25, 2016

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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	3	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 Jun 9, 2016.

Date	Site	Product	Classification	FEI
Jun 9, 2016	Besancon, France	Devices	Official Action Indicated (OAI)	3010149375

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means 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.

Facility	Location	Inspections	Latest
FEI 3010149375	Besancon, France	1	Jun 9, 2016

Recent 510(k) Clearances

3 510(k) clearances from Jul 31, 2012 to Aug 25, 2016.

K-Number	Device	Date
K153494	HQS Introducer (Model 2064-HQS)	Aug 25, 2016
K133296	XCATH	Feb 14, 2014
K113849	HQS INTRODUCER	Jul 31, 2012

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