Implantica CE Reflux Ltd

FDA Regulatory Profile

Implantica CE Reflux Ltd has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Implantica CE Reflux Ltd" and its spelling variant "Implantica Ce Reflux".

Latest inspection
Oct 24, 2025 · NAI

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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
Inspections1Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA inspections

1 inspection on Oct 24, 2025.

DateSiteProductClassificationFEI
Oct 24, 2025San Gwann, MaltaDevicesNo Action Indicated (NAI)3015217460
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 3015217460San Gwann, Malta1Oct 24, 2025

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