Company · US

Advamedica, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2023. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	3
KGN	Wound Dressing With Animal-Derived Material(S)	1
POD	Temporary, Internal Use Hemostatic	1

Decided	510(k)	Device and applicant	Code
Aug 24, 2023	K212766	Maxiocel Chitosan Wound Dressing Advamedica, Inc.	KGN
Apr 7, 2023	K222909	Axiostat Gauze Advamedica, Inc.	QSY
Jan 5, 2023	K213198	Ax-Surgi Surgical Hemostat Advamedica, Inc.	POD
Apr 15, 2021	K202830	Axiostat Patch Advamedica, Inc.	QSY
Feb 23, 2018	K172324	Axiostat Chitosan Hemostatic Dressing Advamedica, Inc.	QSY

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.