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I.E.M. GmbH FDA Record

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

I.E.M. GmbH has 0 FDA recalls, 0 inspections, 5 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "I.E.M. GmbH" is on file.

What these totals cover: FDA records filed under the name "I.E.M. GmbH" and its spelling variant "I.E.M". Records filed under related names are not included; see Related names.

Latest 510(k): Jul 19, 2016

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	5	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 I.E.M. GmbH above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Iem	Same company group	0	0	3	1	—

Recent 510(k) clearances

5 510(k) clearances from Jun 18, 2004 to Jul 19, 2016.

K-Number	Device	Date
K153557	ABPM 7100, Hypertension Management Software	Jul 19, 2016
K140928	ABPM7100	Sep 15, 2014
K110603	HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)	Dec 16, 2011
K072446	MOBIL-O-GRAPH NG 24 H ABP-CONTROL	Nov 29, 2007
K041313	STABIL-O-GRAPH	Jun 18, 2004

I.E.M. GmbH and the FDA: common questions

Has I.E.M. GmbH received an FDA warning letter?

No FDA warning letter addressed to the name "I.E.M. GmbH" 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 I.E.M. GmbH received an FDA Form 483?

FDA has not published a Form 483 for "I.E.M. GmbH" in its reading room. FDA publishes some Form 483s, not all of them.

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