Home / Companies / Cardionics, Inc.

Cardionics, Inc.

FDA Regulatory Profile

Cardionics, Inc. has 0 FDA recalls, 3 inspections, 2 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Cardionics, Inc." and its spelling variant "Cardionics".

Latest inspection: Aug 30, 2023 · VAI
Latest 510(k): Dec 27, 2000

Reviewing Cardionics, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Cardionics, Inc. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Is this your company or a supplier you list? Link to this FDA record from your site with a free button.

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	3	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

Recent FDA inspections

3 inspections from Jul 23, 2010 to Aug 30, 2023.

Date	Site	Product	Classification	FEI
Aug 30, 2023	Webster, TX	Devices	Voluntary Action Indicated (VAI)	1629623
Jul 29, 2015	Sint-Jans-Molenbeek, Belgium	Devices	Official Action Indicated (OAI)	3003675391
Jul 23, 2010	Webster, TX	Devices	No Action Indicated (NAI)	1629623

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 Cardionics, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Oct 21, 2015.

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

FDA-inspected facilities

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 1629623	Webster, TX	2	Aug 30, 2023
FEI 3003675391	Sint-Jans-Molenbeek, Belgium	1	Jul 29, 2015

Recent 510(k) clearances

2 510(k) clearances from Aug 18, 1986 to Dec 27, 2000.

K-Number	Device	Date
K002197	CARTOUCH	Dec 27, 2000
K862776	SPECTRUM POLYCORD I RECORDER SYSTEM	Aug 18, 1986

Need more than this page shows? Ask about Cardionics, Inc. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.