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H.B. Fuller Medical Adhesive Technologies, LLC: FDA-registered device maker in Hudson, NC, United States, 9 510(k) clearances

Name: H.B. Fuller Medical Adhesive Technologies, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

H.B. Fuller Medical Adhesive Technologies, LLC is registered with the FDA (registration 3006385287) in Hudson, NC, United States. It lists 3 device types. The FDA files 9 510(k) clearances under its listings, the newest dated September 29, 2017. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3006385287
Address: 506 Pine Mountain Rd, Hudson, NC, United States, 28638
Owner or operator: H.B. Fuller Medical Adhesive Technologies, LLC (9103442)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: June 25, 2007
Registered through: 2026
Brand names listed: FloraSeal® Microbial Sealant, Histoacryl & Blue Histoacryl, Histoacryl Flex, Histoacryl, Histoacryl Blue, & Histoacryl Flex with Applicator Tip, SecurePortIV, SurgiSeal Stylus® Topical Skin Adhesive, SurgiSeal Twist® Topical Skin Adhesive, SurgiSeal® Topical Skin Adhesive

Devices it lists

Device	Product code	Class	Role	Source
Bandage, Liquid	KMF	1	Manufacturer	accessdata.fda.gov
Sealant, Microbial	NZP	2	Manufacturer	accessdata.fda.gov
Tissue Adhesive For The Topical Approximation Of Skin	MPN	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 29, 2017	K170505	SecurePortIV Catheter Securement Adhesive	NZP	Substantially Equivalent	Adhezion Biomedical, LLC	accessdata.fda.gov
May 13, 2014	K140343	AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP	MPN	Substantially Equivalent	Aesculap, Inc.	accessdata.fda.gov
May 31, 2013	K130474	SURGISEAL TOPICAL SKIN ADHESIVE	MPN	Substantially Equivalent	Adhezion Biomedical, LLC	accessdata.fda.gov
May 17, 2013	K121976	AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE	MPN	Substantially Equivalent	Aesculap, Inc.	accessdata.fda.gov
April 24, 2013	K123936	SURGISEAL TOPICAL SKIN ADHESIVE	MPN	Substantially Equivalent	Adhezion Biomedical, LLC	accessdata.fda.gov
February 6, 2012	K111959	AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE	MPN	Substantially Equivalent	Aesculap, Inc.	accessdata.fda.gov
July 20, 2009	K083354	FLORASEAL, MODEL FS350D	NZP	Substantially Equivalent	Adhezion Biomedical	accessdata.fda.gov
December 19, 2008	K082993	SURGISEAL TOPICAL SKIN ADHESIVE	MPN	Substantially Equivalent	Adhezion Biomedical	accessdata.fda.gov
May 2, 2007	K063202	PRODERMA LIQUID BANDAGE	KMF	Substantially Equivalent	Procurement Technology Systems, LLC	accessdata.fda.gov

Compare with other makers

Updated September 29, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.