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Trudell Medical Int'L FDA Record

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

Trudell Medical Int'L has 0 FDA recalls, 0 inspections, 3 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Trudell Medical Int'L" is on file.

What these totals cover: FDA records filed under the name "Trudell Medical Int'L". Records filed under related names are not included; see Related names.

Latest 510(k): Aug 15, 2014

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	0	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Trudell Medical Int'L above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Trudell Medical Intl	Same company group	0	12	0	0	—

Recent 510(k) clearances

3 510(k) clearances from Sep 14, 1999 to Aug 15, 2014.

K-Number	Device	Date
K140919	RESPICONNECT ADAPTER	Aug 15, 2014
K001137	AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)	Jul 5, 2000
K992917	AEROCHAMBER PLUS VALVED HOLDING CHAMBER	Sep 14, 1999

Trudell Medical Int'L and the FDA: common questions

Has Trudell Medical Int'L received an FDA warning letter?

No FDA warning letter addressed to the name "Trudell Medical Int'L" 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 Trudell Medical Int'L received an FDA Form 483?

FDA has not published a Form 483 for "Trudell Medical Int'L" in its reading room. FDA publishes some Form 483s, not all of them.

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