GENZYME CORPORATION

Matched from indexed company URL: Genzyme Corporation

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1220423	1220423	GENZYME CORPORATION	1	N	2026-01-01	76 NEW YORK AVENUE FRAMINGHAM MA US 01701
3009389940	3009389940	GENZYME COPORATION	1	N	2026-01-01	11 Forbes Road Northborough MA US 01532
3039908023	3039908023	GENZYME CORPORATION	1	N	2026-01-01	1125 PLEASANTVIEW TERRACE Ridgefield NJ US 07657

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID	Product	Phone	Email
00358468430120	Seprafilm® - Barrier, Absorbable, Adhesion	+1(508)271-3304	paul.dawidczykjr@genzyme.com
00358468508621	Seprafilm® Procedure Pack - Barrier, Absorbable, Adhesion	+1(508)661-1471	brian.nelson@genzyme.com
00358468638014	Seprafilm® 4-section - Barrier, Absorbable, Adhesion	+1(508)661-1471	brian.nelson@genzyme.com
00358468664112	Seprafilm® Single Site - Barrier, Absorbable, Adhesion	+1(508)661-1471	brian.nelson@genzyme.com
00358468664211	Seprafilm® Small Incision - Barrier, Absorbable, Adhesion	+1(508)661-1471	brian.nelson@genzyme.com

genzyme.com

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
43413	1988041851	P950034	SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE	MCN	1996-08-12
12349	1290652414	P940015	SYNVISC ONE	MOZ	1997-08-08
43413	1685288049
237819	1467778901
43413	1988041851

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
MOZ	2	1997-08-08
MCN	1	1996-08-12

NDC

Thyrogen

Genzyme Corporation

THYROTROPIN ALFA

Fabrazyme

Genzyme Corporation

AGALSIDASE BETA

Fabrazyme

Genzyme Corporation

AGALSIDASE BETA

XENPOZYME

Genzyme Corporation

olipudase alfa-rpcp

XENPOZYME

Genzyme Corporation

olipudase alfa-rpcp

ALDURAZYME

Genzyme Corporation

laronidase

Thymoglobulin

Genzyme Corporation

Anti-thymocyte Globulin (Rabbit)

Renvela

Genzyme Corporation

SEVELAMER CARBONATE

Renvela

Genzyme Corporation

SEVELAMER CARBONATE

Renvela

Genzyme Corporation

SEVELAMER CARBONATE

Lumizyme

Genzyme Corporation

ALGLUCOSIDASE ALFA

LEMTRADA

Genzyme Corporation

ALEMTUZUMAB

Aubagio

Genzyme Corporation

teriflunomide

Aubagio

Genzyme Corporation

teriflunomide

Cerdelga

Genzyme Corporation

eliglustat

Cablivi

Genzyme Corporation

caplacizumab

WAYRILZ

Genzyme Corporation

rilzabrutinib

Qfitlia

Genzyme Corporation

fitusiran

Qfitlia

Genzyme Corporation

fitusiran

Campath

Genzyme Corporation

ALEMTUZUMAB

Nexviazyme

Genzyme Corporation

avalglucosidase alfa-ngpt

Cerezyme

Genzyme Corporation

IMIGLUCERASE

CAPRELSA

Genzyme Corporation

Vandetanib

CAPRELSA

Genzyme Corporation

Vandetanib

PMA

Seprafilm Adhesion Barrier

2018-03-09

GENZYME CORP.

Seprafilm Adhesion Barrier

2017-10-25

GENZYME CORP.

Seprafilm Adhesion Barrier

2017-08-29

GENZYME CORP.

SEPRAFILM ADHESION BARRIER

2017-06-29

GENZYME CORP.

SEPRAFILM ADHESION BARRIER

2016-11-14

GENZYME CORP.

SEPRAFILM ADHESION BARRIER

2016-01-14

GENZYME CORP.

SEPRAFILM ADHESION BARRIER

2016-01-07

GENZYME CORP.

SEPRAFILM ADHESION BARRIER

2015-12-03

GENZYME CORP.

PREVELLE SILK

2014-09-05

GENZYME BIOSURGERY

SEPRAFILM ADHESION BARRIER

2014-08-12

GENZYME CORP.

PREVELLE SILK

2014-08-06

GENZYME BIOSURGERY

LEGOO

2014-03-26

GENZYME CORP.

LEGOO ENDOVASCULAR OCCLUSION GEL

2012-11-13

GENZYME CORP.

LEGOO

2012-11-13

GENZYME CORP.

PREVELLE SILK

2012-05-03

GENZYME BIOSURGERY

SEPRAFILM

2012-04-04

GENZYME CORP.

LEGOO ENDOVASCULAR OCCLUDER

2012-03-01

GENZYME CORP.

SEPRAFILM

2012-02-17

GENZYME CORP.

PREVELLE SILK

2011-10-07

GENZYME BIOSURGERY

LEGOO

2011-09-28

GENZYME CORP.

HYLAFORM (HYLAN B GEL); PREVELLE SILK

2011-07-18

GENZYME BIOSURGERY

SEPRAFILM

2011-01-20

GENZYME CORP.

SEPRAFILM ADHESION BARRIER

2011-01-19

GENZYME CORP.

SEPRAFILM ADHESION BARRIER

2010-12-22

GENZYME CORP.

SEPRAFILM

2010-12-02

GENZYME CORP.

SEPRAFILM

2010-10-26

GENZYME CORP.

SEPRAFILM

2010-10-07

GENZYME CORP.

PREVELLE SILK

2010-09-15

GENZYME BIOSURGERY

SEPRAFILM

2010-09-14

GENZYME CORP.

HYLAFORM FAMILY DERMAL FILLERS (HYLAFORM, HYLAFORM PLUS AND CAPTIQUE INJECTABLE GEL)

2010-02-24

GENZYME BIOSURGERY

SEPRAFILM ADHESION BARRIER

2009-11-30

GENZYME CORP.

PREVELLE SILK & HYLAN B GEL

2009-10-09

GENZYME BIOSURGERY

SEPRAFILM ADHESION BARRIER

2008-06-20

GENZYME CORP.

PREVELLE SILK

2008-02-26

GENZYME BIOSURGERY

SEPRAFILM ADHESION BARRIER

2007-07-11

GENZYME CORP.

HYLAFORM (HYLAN B GEL), HYLAFORM PLUS, CAPTIQUE

2006-02-28

GENZYME BIOSURGERY

SEPRAFILM ADHESION BARRIER

2005-12-05

GENZYME CORP.

HYLAFORM AND HYLAFORM PLUS

2005-11-02

GENZYME BIOSURGERY

HYLAFORM, HYLAFORM PLUS, ND CAPTIQUE

2005-07-01

GENZYME BIOSURGERY

CAPTIQUE INJECTABLE GEL

2004-11-12

GENZYME BIOSURGERY

72 records. Showing 1-40. Next

PMN

OSOM C. DIFFICILE TOXIN A/B TEST

2010-12-21

GENZYME CORPORATION

OSOM INFLUENZA A&B TEST , MODEL PN190

2009-09-25

GENZYME CORPORATION

ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30

2009-05-01

GENZYME DIAGNOSTICS P.E.I. INC.

TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30

2008-12-16

GENZYME DIAGNOSTICS P.E.I. INC.

GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR

2008-05-15

GENZYME CORPORATION

SEPRAMESH, MODEL 5959-1214

2007-01-17

GENZYME CORPORATION

OSOM INFLUENZA A&B TEST

2006-06-12

GENZYME CORP.

GENZYME OSOM INFLUENZA A & B TEST

2006-02-21

GENZYME CORP.

SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH

2005-12-19

GENZYME CORPORATION

SEPRAGEL ENT BIORESORBABLE PACKING/STENT

2005-07-11

GENZYME CORPORATION

OSOM HCG COMBO TEST

2005-04-12

GENZYME DIAGNOSTICS

N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET

2004-06-25

GENZYME CORP.

SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH

2004-06-04

GENZYME CORP.

GENZYME OSOM TRICHOMONAS RAPID TEST

2004-04-02

GENZYME CORP.

S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM

2003-07-25

GENZYME BIOSURGERY

MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE

2003-03-27

GENZYME BIOSURGERY

GENZYME CONTRAST II HCG URINE/SERUM TEST

2003-01-16

GENZYME CORP.

RADLITE TISSUE RETRACTOR SYSTEM

2002-11-25

GENZYME BIOSURGERY

SAPH-LOOP LIGATING LOOP

2002-08-20

GENZYME BIOSURGERY

ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR

2002-07-25

GENZYME CORP.

COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE

2002-06-18

GENZYME CORP.

SEPRAGEL SINUS

2001-10-30

GENZYME CORP.

GENZYME DIRECT-AMYLASE TEST REAGENT

2001-08-10

GENZYME CORP.

NEXTSTITCH CARDIOVASCULAR VALVE SUTURE

2000-11-13

GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE

2000-06-12

GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL

2000-03-21

GENZYME CORP.

SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX

2000-03-02

GENZYME CORP.

N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET

1999-10-18

GENZYME CORP.

GENZYME DIRECT AMYLASE VERIFIER

1999-10-04

GENZYME CORP.

BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE

1999-09-03

GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

ENDOSCOPIC CAMERA

1999-07-20

GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE

1999-06-22

GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

SAPHLIFT

1999-03-30

GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY

1999-01-11

GENZYME DIAGNOSTICS

RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250

1998-12-18

GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL

1998-11-25

GENZYME CORP.

MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE

1998-08-07

GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

CUTALON NYLON POLYAMIDE SURGICAL SUTURE

1998-07-07

GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET

1997-06-18

GENZYME CORP.

N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR

1997-06-16

GENZYME CORP.

53 records. Showing 1-40. Next

Applications

761261

GENZYME CORP

761194

GENZYME CORP

219685

GENZYME CORP

219019

GENZYME CORP

205494

GENZYME CORP

19019

GENZYME CORP

125291

GENZYME

125141

GENZYME

103979

GENZYME

103948

GENZYME

075721

GENZYME

022405

GENZYME CORP

022318

GENZYME

022311

GENZYME

021673

GENZYME

021179

GENZYME

020926

GENZYME

020898

GENZYME

020367

GENZYME

020038

GENZYME CORP

GUDID

GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US - 762617

GENZYME CORPORATION

2022-10-19

NEOGAA AVALGLUCO 103MG/20ML MEDSU VL1 U - 785361

GENZYME CORPORATION

2020-07-01

OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US - 785362

GENZYME CORPORATION

2020-07-01

Seprafilm® - Barrier, Absorbable, Adhesion

GENZYME CORPORATION

2014-09-24

Seprafilm® Procedure Pack - Barrier, Absorbable, Adhesion

GENZYME CORPORATION

2014-09-24

Seprafilm® 4-section - Barrier, Absorbable, Adhesion

GENZYME CORPORATION

2014-09-24

Seprafilm® Single Site - Barrier, Absorbable, Adhesion

GENZYME CORPORATION

2014-09-24

Seprafilm® Small Incision - Barrier, Absorbable, Adhesion

GENZYME CORPORATION

2014-09-24

Synvisc-One® - Acid, Hyaluronic, Intraarticular

GENZYME CORPORATION

2014-09-24

Synvisc® - Acid, Hyaluronic, Intraarticular

GENZYME CORPORATION

2014-09-25

LeGoo® LG100 - Occluder, Internal Vessel, Temporary

GENZYME CORPORATION

2014-09-24

LeGoo® LG250 - Occluder, Internal Vessel, Temporary

GENZYME CORPORATION

2014-09-24