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ORGANOGENESIS INC.

Last updated September 17, 2026

Information

Country: US
Address: 150 DAN RD., CANTON, MA, 02021
Website: xx.xx
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 1-888-432-5232
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000148471
DUNS Number: 152165817

Catalogue (40)

Device	Model / Reference	Registries	Class	Status
Dermagraft	1	FDA UDI	Class III	Active
PuraPly™ Antimicrobial XT Wound Matrix	515-017	FDA UDI	U	Active
PuraForce ™	550-004	FDA UDI	U	Active
PuraPly Micronized Wound Matrix (PuraPly MZ)	515-059	FDA UDI	U	Active
PuraPly™ Antimicrobial Wound Matrix	515-065	FDA UDI	U	Active
PuraPly™ Antimicrobial XT Wound Matrix	515-036	FDA UDI	U	Active
PuraPly™ Antimicrobial Wound Matrix	515-067	FDA UDI	U	Unknown
PuraPly™ Antimicrobial Wound Matrix	515-016	FDA UDI	U	Active
PuraPly™ Wound Matrix	515-012	FDA UDI	U	Active
PuraPly™ Antimicrobial Wound Matrix	515-069	FDA UDI	U	Active
PuraPly Micronized Wound Matrix (PuraPly MZ)	515-061	FDA UDI	U	Active
PuraPly™ Antimicrobial XT Wound Matrix	515-034	FDA UDI	Class I	Active
PuraForce™	550-006	FDA UDI	U	Active
TransCyte	10633	FDA UDI	Class III	Active
PuraPly™ Antimicrobial Wound Matrix	1	FDA UDI	U	Active
PuraForce™	550-002	FDA UDI	U	Active
PuraPly™ Antimicrobial Wound Matrix	515-008	FDA UDI	U	Active
PuraPly™ Wound Matrix	515-006	FDA UDI	U	Active
PuraPly™ Wound Matrix	515-010	FDA UDI	U	Active
PuraPly™ Antimicrobial Wound Matrix	515-020	FDA UDI	U	Active
PuraPly™ Wound Matrix	515-024	FDA UDI	U	Active
PuraPly™ Antimicrobial Wound Matrix	515-014	FDA UDI	U	Active
PuraPly™ Antimicrobial Wound Matrix	515-018	FDA UDI	U	Active
PuraPly Micronized Wound Matrix (PuraPly MZ)	515-063	FDA UDI	U	Active
PuraPly™ Wound Matrix	1	FDA UDI	U	Active
Apligraf	1	FDA UDI	Class III	Active
PuraForce™	550-008	FDA UDI	U	Active
Cuffpatch	K042809	FDA 510(k)	Class II	Active
Fortaflex Surgical Mesh	K011025	FDA 510(k)	Class II	Active
Fortaflex Surgical Sling	K011027	FDA 510(k)	Class II	Active
Fortaflex Surgical Mesh	K021105	FDA 510(k)	Class II	Active
PuraPly Micronized Wound Matrix (PuraPly MZ)	K220317	FDA 510(k)	U	Active
Fortaderm Wound Dressing	K011026	FDA 510(k)	U	Active
Fortaflex Surgical Mesh	K020049	FDA 510(k)	Class II	Active
Fortaflex Surgical Sling	K021107	FDA 510(k)	Class II	Active
Graft Patch	K970561	FDA 510(k)	Class II	Active
FortiShield (Biosynthetic Wound Matrix)	K212579	FDA 510(k)	U	Active
Fortagen Oral Membrane	K071555	FDA 510(k)	Class II	Active
Fortaderm Antimicrobial Wound Dressing	K051647	FDA 510(k)	U	Active
Apligraf	P950032	FDA PMA	Class III	Active

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Authorities

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FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 21, 2011	Z-1747-2011	—	terminated	Product sterility may be compromised
Jan 30, 2011	Z-1746-2011	—	terminated	Product sterility compromised
Aug 2, 2010	Z-2589-2010	—	terminated	Product is contaminated with a yeast identified as Pseudozyma antarctica.
Sep 27, 2009	Z-0181-2010	—	terminated	Unit contaminated with Staphylococcus epidermidis
Dec 26, 2007	Z-0675-2008	—	terminated	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.
Sep 29, 2006	Z-0068-2007	—	terminated	Product pH out of specification