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Meditech Kft.

FDA Regulatory Profile

Meditech Kft. 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 "Meditech Kft." and its spelling variant "Meditech Kft". Records filed under related names are not included; see Related names.

Latest inspection: Jun 28, 2018 · VAI
Latest 510(k): Aug 3, 2007

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

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 Meditech Kft. above.

Name	Relation	510(k)	Most recent recall
Medi-Tech	Same company group	36	—
Meditech	Same company group	3	—
Meditech Gloves	Same company group	2	—

Recent FDA inspections

3 inspections from Apr 13, 2012 to Jun 28, 2018.

Date	Site	Product	Classification	FEI
Jun 28, 2018	Budapest, Hungary	Devices	Voluntary Action Indicated (VAI)	3003764019
Jan 15, 2015	Budapest, Hungary	Devices	Voluntary Action Indicated (VAI)	3003764019
Apr 13, 2012	Budapest, Hungary	Devices	Official Action Indicated (OAI)	3003764019

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

Most recent: Warning Letter, Jul 18, 2012.

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 3003764019	Budapest, Hungary	3	Jun 28, 2018

Recent 510(k) clearances

2 510(k) clearances from Nov 18, 2005 to Aug 3, 2007.

K-Number	Device	Date
K071960	MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05	Aug 3, 2007
K051149	MEDITECH MODEL ABPM-04	Nov 18, 2005

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