Organogenesis, Inc.

Canton, MA, US

ORGANOGENESIS INC. appears in FDA device records in Canton, MA. FDA records list 12 510(k) clearances between 1997-08-01 and 2023-05-02, 67 PMA records and one registered establishment. As of 2026-09-10, FDA records show 7 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 12
PMA records: 67
Recall records: 7
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Organogenesis, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Smith and Nephew Wound Management (La Jolla)recall

510(k) clearance history

FDA records hold 12 510(k) clearances for Organogenesis, Inc. between 1997 and 2023. The busiest year on record is 2001, with 3. The most recent is 2023, with 1.

Clearances by year, as a table

510(k) clearance decisions for Organogenesis, Inc., by decision year
Year	Clearances
1997	1
2001	3
2002	3
2004	1
2005	1
2007	1
2022	1
2023	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K212579	FortiShield (Biosynthetic Wound Matrix)	KGN	Substantially Equivalent	2023-05-02
K220317	PuraPly Micronized Wound Matrix (PuraPly MZ)	KGN	Substantially Equivalent	2022-07-01
K071555	FORTAGEN ORAL MEMBRANE	NPL	Substantially Equivalent	2007-08-30
K051647	FORTADERM ANTIMICROBIAL WOUND DRESSING	FRO	Substantially Equivalent	2005-11-08
K042809	CUFFPATCH	FTM	Substantially Equivalent	2004-11-02
K021107	FORTAFLEX SURGICAL SLING	FTM	Substantially Equivalent	2002-05-15
K021105	FORTAFLEX SURGICAL MESH	FTM	Substantially Equivalent	2002-05-10
K020049	FORTAFLEX SURGICAL MESH	FTM	Substantially Equivalent	2002-03-18
K011025	FORTAFLEX SURGICAL MESH	FTM	Substantially Equivalent	2001-08-24
K011026	FORTADERM WOUND DRESSING	KGN	Substantially Equivalent	2001-06-13
K011027	FORTAFLEX SURGICAL SLING	FTM	Substantially Equivalent	2001-05-30
K970561	GRAFT PATCH	FTL	Substantially Equivalent	1997-08-01

Registered establishments

FDA registered establishments for Organogenesis, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1221816	1000148471	ORGANOGENESIS INC.	150 DAN RD., CANTON, MA 02021 US	2026	FRO FTM KGN MGR PFC

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Initiated	Status
Z-1747-2011	Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living, bilayered skin substitute	Product sterility may be compromised	2011-02-21	Terminated
Z-1746-2011	Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living, bi-layered skin substitute	Product sterility compromised	2011-01-30	Terminated
Z-2589-2010	Apligraf is supplied as a living, bi-layered skin substitute. Article Number: GS100 Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy.	Product is contaminated with a yeast identified as Pseudozyma antarctica.	2010-08-02	Terminated
Z-0181-2010	Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers and for the treatment of full-thickness neuropathic diabetic foot ulcers.	Unit contaminated with Staphylococcus epidermidis	2009-09-27	Terminated
Z-0675-2008	Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton, Massachusetts 02021	Contamination: Apligraf units were reported to have contamination in the agarose nutrient medium of some units retained at Organogenesis. Preliminary tests show a gram negative rod (bacillus) organism.	2007-12-26	Terminated
Z-0068-2007	Apligraf (Graftskin)	Product pH out of specification	2006-09-29	Terminated
Z-0904-03	Dermagraft, Human Fibroblast -Derived Dermal Substitute, 2 in. by 3 in..	Did not meet finished device specifications for the DNA criteria.	2003-05-02	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain