Organogenesis Inc

FDA Filings

This page includes the latest FDA filings for Organogenesis Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 2028403
• FEI Number: 1000096732
• Name: Organogenesis Inc.
• Owner & Operator: ORGANOGENESIS, INC.
• Contact Address: 150 DAN RD. --; Canton MA 02021 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 10933 North Torrey Pines Road ; La Jolla, CA 92037 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 1221816
• FEI Number: 1000148471
• Name: ORGANOGENESIS, INC.
• Owner & Operator: ORGANOGENESIS, INC.
• Contact Address: 150 DAN RD. --; Canton MA 02021 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 150 DAN RD. ; CANTON, MA 02021 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00618474000411 ORGANOGENESIS INC.	PuraPly Micronized Wound Matrix (PuraPly MZ)	2023-05-09
GUDID 00618474000404 ORGANOGENESIS INC.	PuraPly Micronized Wound Matrix (PuraPly MZ)	2023-05-09
GUDID 00618474000398 ORGANOGENESIS INC.	PuraPly Micronized Wound Matrix (PuraPly MZ)	2023-05-09
PMN K220317 Organogenesis Inc.	PuraPly Micronized Wound Matrix (PuraPly MZ)	2022-07-01
GUDID 00618474000466 ORGANOGENESIS INC.	PuraPly™ Antimicrobial XT Wound Matrix	2021-12-09
GUDID 00618474000459 ORGANOGENESIS INC.	PuraPly™ Antimicrobial Wound Matrix	2021-04-14
GUDID 00618474000442 ORGANOGENESIS INC.	PuraPly™ Antimicrobial Wound Matrix	2021-04-14
GUDID 00618474000435 ORGANOGENESIS INC.	PuraPly™ Antimicrobial Wound Matrix	2020-10-12
GUDID 00618474000282 ORGANOGENESIS INC.	PuraPly™ Antimicrobial XT Wound Matrix	2020-05-06
GUDID 00618474000275 ORGANOGENESIS INC.	PuraPly™ Antimicrobial XT Wound Matrix 515-034	2020-05-06
GUDID 00618474000237 ORGANOGENESIS INC.	PuraForce™	2020-05-06
GUDID 00618474000220 ORGANOGENESIS INC.	PuraForce™	2020-05-06
GUDID 00618474000213 ORGANOGENESIS INC.	PuraForce ™	2020-05-06
GUDID 00618474000206 ORGANOGENESIS INC.	PuraForce™	2020-05-06
GUDID 00618474000152 ORGANOGENESIS INC.	PuraPly™ Wound Matrix	2020-05-06
GUDID 00618474000121 ORGANOGENESIS INC.	PuraPly™ Antimicrobial Wound Matrix	2020-05-06
GUDID 00618474000114 ORGANOGENESIS INC.	PuraPly™ Antimicrobial Wound Matrix	2020-05-06
GUDID 00618474000107 ORGANOGENESIS INC.	PuraPly™ Antimicrobial Wound Matrix	2020-05-06
GUDID 00618474000091 ORGANOGENESIS INC.	PuraPly™ Antimicrobial Wound Matrix	2020-05-06
GUDID 00618474000084 ORGANOGENESIS INC.	PuraPly™ Antimicrobial Wound Matrix	2020-05-06
GUDID 00618474000060 ORGANOGENESIS INC.	PuraPly™ Wound Matrix	2020-05-06
GUDID 00618474000053 ORGANOGENESIS INC.	PuraPly™ Wound Matrix	2020-05-06
GUDID 00618474000039 ORGANOGENESIS INC.	PuraPly™ Antimicrobial Wound Matrix	2020-05-06
GUDID 00618474000022 ORGANOGENESIS INC.	PuraPly™ Wound Matrix	2020-05-06
GUDID 00618474000046 ORGANOGENESIS INC.	TransCyte	2019-12-03
GUDID 00061874000282 ORGANOGENESIS INC.	PuraPly™ Antimicrobial XT Wound Matrix	2019-10-09
GUDID 00618474000015 ORGANOGENESIS INC.	Dermagraft	2018-07-06
GUDID 00618474000008 ORGANOGENESIS INC.	Apligraf	2018-03-29
PMN BP960700 | MGR Organogenesis Inc. [ORGANOGENESIS, INC.]	TransCyte	2017-01-26
PMN BP953200 | PFC ORGANOGENESIS, INC.	Apligraf	2016-01-18
PMN K051647 | FRO ORGANOGENESIS, INC.	PuraPly Antimicrobial XT Wound Matrix (6cm x 9cm)	2015-02-05
PMN K051647 | FRO ORGANOGENESIS, INC.	PuraPly Antimicrobial XT Wound Matrix (5cm x 5cm)	2015-02-05
PMN K051647 | FRO ORGANOGENESIS, INC.	PuraPly Antimicrobial Wound Matrix (8cm x 16cm)	2015-02-05
PMN K051647 | FRO ORGANOGENESIS, INC.	PuraPly Antimicrobial Wound Matrix (6cm x 9cm)	2015-02-05
PMN K051647 | FRO ORGANOGENESIS, INC.	PuraPly Antimicrobial Wound Matrix (5cm x 5cm)	2015-02-05
PMN K051647 | FRO ORGANOGENESIS, INC.	PuraPly Antimicrobial Wound Matrix (4.0cm x 4.0cm)	2015-02-05
PMN K051647 | FRO ORGANOGENESIS, INC.	PuraPly Antimicrobial Wound Matrix (3.76cm x 3.76cm)	2015-02-05
PMN K051647 | FRO ORGANOGENESIS, INC.	PuraPly Antimicrobial Wound Matrix (3.02cm x 3.02cm)	2015-02-05
PMN K051647 | FRO ORGANOGENESIS, INC.	PuraPly Antimicrobial Wound Matrix (2cm x 4cm)	2015-02-05
PMN K051647 | FRO ORGANOGENESIS, INC.	PuraPly Antimicrobial Wound Matrix (2cm x 2cm)	2015-02-05
PMN K051647 | FRO ORGANOGENESIS, INC.	PuraPly Antimicrobial Wound Matrix (2.05cm x 3.05cm)	2015-02-05
PMN K051647 | FRO ORGANOGENESIS, INC.	PuraPly Antimicrobial Wound Matrix (1.88cm x 1.88cm)	2015-02-05
PMN K051647 | FRO ORGANOGENESIS, INC.	PuraPly Antimicrobial Wound Matrix (1.6cm Disc)	2015-02-05
PMN K051647 | FRO ORGANOGENESIS, INC.	PuraPly Antimicrobial Wound Matrix (1.4cm Disc)	2015-02-05
PMN K051647 | FRO ORGANOGENESIS, INC.	PuraPly Antimicrobial Wound Matrix (1.25cm x 2.00cm)	2015-02-05
PMN K051647 | FRO ORGANOGENESIS, INC.	FortaDerm Antimicrobial Wound Dressing	2015-02-05
PMN K011026 | KGN ORGANOGENESIS, INC.	PuraPly Wound Matrix (6cm x 9cm)	2015-02-05
PMN K011026 | KGN ORGANOGENESIS, INC.	PuraPly Wound Matrix (5cm x 5cm)	2015-02-05
PMN K011026 | KGN ORGANOGENESIS, INC.	PuraPly Wound Matrix (2cm X 4cm)	2015-02-05
PMN K011026 | KGN ORGANOGENESIS, INC.	PuraPly Wound Matrix (2.05cm x 3.05cm)	2015-02-05
PMN K011026 | KGN ORGANOGENESIS, INC.	FortaDerm Wound Dressing	2015-02-05
PMA P950032S070 ORGANOGENESIS, INC.	APLIGRAF	2014-03-10
PMN BP003600 | PFC Organogenesis Inc. [ORGANOGENESIS, INC.]	Dermagraft	2014-02-13
PMA P950032S074 ORGANOGENESIS, INC.	APLIGRAF	2013-08-13
PMA P950032S072 ORGANOGENESIS, INC.	APLIGRAF	2013-07-11
PMA P950032S073 ORGANOGENESIS, INC.	APLIGRAF	2013-06-25
PMA P950032S071 ORGANOGENESIS, INC.	APLIGRAF	2013-03-14
PMA P950032S069 ORGANOGENESIS, INC.	APLIGRAF	2012-11-20
GINTUIT Organogenesis, Inc	Other Medication	2012-04-18
PMA P950032S068 ORGANOGENESIS, INC.	APLIGRAF	2012-04-03
NDC 42606-004 Organogenesis, Inc	GINTUIT	2012-03-15
PMA P950032S067 ORGANOGENESIS, INC.	APLIGRAF	2012-02-22
PMA P950032S066 ORGANOGENESIS, INC.	APLIGRAF	2011-12-28
PMA P950032S065 ORGANOGENESIS, INC.	APLIGRAF	2011-11-22
PMA P950032S064 ORGANOGENESIS, INC.	APLIGRAF	2011-09-22
PMA P950032S063 ORGANOGENESIS, INC.	APLIGRAF	2011-04-06
PMA P950032S059 ORGANOGENESIS, INC.	APLIGRAF	2011-02-14
PMA P950032S062 ORGANOGENESIS, INC.	APLIGRAF	2011-02-10
PMA P950032S061 ORGANOGENESIS, INC.	APLIGRAF	2011-01-07
PMA P950032S060 ORGANOGENESIS, INC.	APLIGRAF	2010-10-26
PMA P950032S045 ORGANOGENESIS, INC.	APLIGRAF	2010-08-17
PMA P950032S058 ORGANOGENESIS, INC.	APLIGRAF	2010-07-27
PMA P950032S057 ORGANOGENESIS, INC.	APLIGRAF	2010-04-09
PMA P950032S056 ORGANOGENESIS, INC.	APLIGRAF	2010-04-09
PMA P950032S054 ORGANOGENESIS, INC.	APLIGRAF	2009-12-29
PMA P950032S055 ORGANOGENESIS, INC.	APLIGRAF	2009-12-23
PMA P950032S052 ORGANOGENESIS, INC.	APLIGRAF	2009-11-03
PMA P950032S053 ORGANOGENESIS, INC.	APLIGRAF	2009-09-03
PMA P950032S051 ORGANOGENESIS, INC.	APLIGRAF	2009-05-19
PMA P950032S050 ORGANOGENESIS, INC.	APLIGRAF	2009-03-13
PMA P950032S049 ORGANOGENESIS, INC.	APLIGRAF	2008-12-10
PMA P950032S048 ORGANOGENESIS, INC.	APLIGRAF	2008-07-16
PMA P950032S047 ORGANOGENESIS, INC.	APLIGRAF	2008-05-19
PMA P950032S046 ORGANOGENESIS, INC.	APLIGRAF	2008-03-19
PMN K042809 | FTM ORGANOGENESIS, INC.	PuraForce 8cm x 4cm (Previously known as CuffPatch and Inforce)	2007-11-27
PMN K042809 | FTM ORGANOGENESIS, INC.	PuraForce 6cm x 3cm (Previously known as CuffPatch and Inforce)	2007-11-27
PMN K042809 | FTM ORGANOGENESIS, INC.	PuraForce 6cm x 2cm (Previously known as CuffPatch and Inforce)	2007-11-27
PMN K042809 | FTM ORGANOGENESIS, INC.	PuraForce 6.5cm x 9cm (Previously known as CuffPatch and Inforce)	2007-11-27
PMN K071555 ORGANOGENESIS, INC.	FORTAGEN ORAL MEMBRANE	2007-08-30
PMA P950032S044 ORGANOGENESIS, INC.	APLIGRAF	2007-07-13
PMA P950032S043 ORGANOGENESIS, INC.	APLIGRAF	2006-04-21
PMN K051647 ORGANOGENESIS, INC.	FORTADERM ANTIMICROBIAL WOUND DRESSING	2005-11-08
PMA P950032S041 ORGANOGENESIS, INC.	APLIGRAF	2005-06-20
PMA P950032S040 ORGANOGENESIS, INC.	APLIGRAF	2005-04-25
PMN K042809 ORGANOGENESIS, INC.	CUFFPATCH	2004-11-02
PMA P950032S038 ORGANOGENESIS, INC.	APLIGRAF	2004-06-14
PMA P950032S037 ORGANOGENESIS, INC.	APILGRAF	2004-01-23
PMA P950032S036 ORGANOGENESIS, INC.	APLIGRAF	2003-10-24
PMA P950032S035 ORGANOGENESIS, INC.	APLIGRAF	2003-09-15
PMA P950032S034 ORGANOGENESIS, INC.	APLIGRAF	2002-10-15
PMA P950032S033 ORGANOGENESIS, INC.	APLIGRAF	2002-08-12
PMA P950032S032 ORGANOGENESIS, INC.	APLIGRAF	2002-07-02
PMN K021107 ORGANOGENESIS, INC.	FORTAFLEX SURGICAL SLING	2002-05-15
PMN K021105 ORGANOGENESIS, INC.	FORTAFLEX SURGICAL MESH	2002-05-10
PMA P950032S031 ORGANOGENESIS, INC.	APLIGRAF	2002-04-09
PMN K020049 ORGANOGENESIS, INC.	FORTAFLEX SURGICAL MESH	2002-03-18
PMA P950032S029 ORGANOGENESIS, INC.	APLIGRAF	2002-03-14
PMA P950032S028 ORGANOGENESIS, INC.	APILGRAF(GRAFTSKIN)	2002-01-17
PMA P950032S019 ORGANOGENESIS, INC.	APLIGRAF(R)(GRAFTSKIN)	2001-11-19
PMA P950032S027 ORGANOGENESIS, INC.	APLIGRAF (GRAFTSKIN)	2001-11-07
PMA P950032S020 ORGANOGENESIS, INC.	APLIGRAF (GRAFTSKIN)	2001-11-07
PMA P950032S026 ORGANOGENESIS, INC.	APLIGRAF (GRAFTSKIN)	2001-09-14
PMN K011025 ORGANOGENESIS, INC.	FORTAFLEX SURGICAL MESH	2001-08-24
PMA P950032S025 ORGANOGENESIS, INC.	APLIGRAF (GRAFTSKIN)	2001-08-10
PMA P950032S024 ORGANOGENESIS, INC.	APLIGRAF/GRAFTSKIN	2001-07-16
PMN K011026 ORGANOGENESIS, INC.	FORTADERM WOUND DRESSING	2001-06-13
PMN K011027 ORGANOGENESIS, INC.	FORTAFLEX SURGICAL SLING	2001-05-30
PMA P950032S023 ORGANOGENESIS, INC.	APLIGRAF(R)	2001-05-09
PMA P950032S022 ORGANOGENESIS, INC.	APLIGRAF(GRAFTSKIN)	2001-04-26
PMA P950032S021 ORGANOGENESIS, INC.	APLIGRAF(R)(GRAFTSKIN)	2000-12-21
PMA P950032S018 ORGANOGENESIS, INC.	APLIGRAF(R)	2000-08-31
PMA P950032S016 ORGANOGENESIS, INC.	APLIGRAF (GRAFTSKIN)	2000-06-20
PMA P950032S017 ORGANOGENESIS, INC.	APLIGRAF(R)(GRAFTSKIN)	2000-06-16
PMA P950032S010 ORGANOGENESIS, INC.	APLIGRAF (GRAFTSKIN)	2000-05-03
PMA P950032S014 ORGANOGENESIS, INC.	APLIGRAF(R) (GRAFTSKIN)	1999-10-14
PMA P950032S015 ORGANOGENESIS, INC.	APLIGRAF(R)(GRAFTSKIN)	1999-09-28
PMA P950032S011 ORGANOGENESIS, INC.	APLIGRAF (GRAFTSKIN)	1999-06-24
PMA P950032S009 ORGANOGENESIS, INC.	APLIGRAF TM	1999-04-19
PMA P950032S008 ORGANOGENESIS, INC.	APLIGRAF (GRAFTSKIN)	1999-02-23
PMA P950032S007 ORGANOGENESIS, INC.	APLIGRAF (GRAFTSKIN)	1999-02-01
PMA P950032S004 ORGANOGENESIS, INC.	APLIGRAF (GRAFTSKIN)	1999-01-06
PMA P950032S002 ORGANOGENESIS, INC.	APLIGRAF (GRAFTSKIN)	1999-01-06
PMA P950032S001 ORGANOGENESIS, INC.	APLIGRAF (GRAFTSKIN)	1998-07-09
PMA P950032 ORGANOGENESIS, INC.	APLIGRAF (GRAFTSKIN)	1998-05-22
PMN K970561 ORGANOGENESIS, INC.	GRAFT PATCH	1997-08-01

Related Finance Registrations

NCAGE Code	4JB06	ORGANOGENESIS INC.
CAGE Code	4JB06	ORGANOGENESIS INC.
S.A.M. Registration	4JB06 [152165817]	ORGANOGENESIS INC.
SEC	0000779733	ORGANOGENESIS INC of DELAWARE