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Aap Biomaterials GmbH & Co. KG FDA Record

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

No warning letters matched by name

Inspections 0 0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 2 Latest Mar 15, 2013

Aap Biomaterials GmbH & Co. KG has 0 FDA recalls, 0 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Aap Biomaterials GmbH & Co. KG" is on file.

What these totals cover: FDA records filed under the name "Aap Biomaterials GmbH & Co. KG" and its spelling variant "Aap Biomaterials Gmbh And Co. Kg". Records filed under related names are not included; see Related names.

Latest 510(k): Mar 15, 2013

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	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 Aap Biomaterials GmbH & Co. KG above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Aap Biomaterials	Same company group	0	2	2	0	—

Recent 510(k) clearances

2 510(k) clearances from Mar 7, 2013 to Mar 15, 2013.

K-Number	Device	Date
K123225	BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60	Mar 15, 2013
K123081	BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL…	Mar 7, 2013

Aap Biomaterials GmbH & Co. KG and the FDA: common questions

Has Aap Biomaterials GmbH & Co. KG received an FDA warning letter?

No FDA warning letter addressed to the name "Aap Biomaterials GmbH & Co. KG" 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 Aap Biomaterials GmbH & Co. KG received an FDA Form 483?

FDA has not published a Form 483 for "Aap Biomaterials GmbH & Co. KG" in its reading room. FDA publishes some Form 483s, not all of them.

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