Genzyme Corporation
Framingham, MA, US
GENZYME CORPORATION appears in FDA device records in Framingham, MA. FDA records list 33 510(k) clearances between and , 11 PMA records and 3 registered establishments. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Genzyme Corporation 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.
- Vericel Corporationregistration
510(k) clearance history
FDA records hold 33 510(k) clearances for Genzyme Corporation between 1991 and 2010. The busiest year on record is 1993, with 3. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 2 |
| 1992 | 1 |
| 1993 | 3 |
| 1995 | 1 |
| 1996 | 2 |
| 1997 | 3 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 2 |
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 2 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K102242 | OSOM C. DIFFICILE TOXIN A/B TEST | LLH | Substantially Equivalent | |
| K092633 | OSOM INFLUENZA A&B TEST , MODEL PN190 | PSZ | Substantially Equivalent | |
| K080662 | GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR | NDY | Substantially Equivalent | |
| K063739 | SEPRAMESH, MODEL 5959-1214 | FTL | Substantially Equivalent | |
| K061508 | OSOM INFLUENZA A&B TEST | PSZ | Substantially Equivalent | |
| K051244 | GENZYME OSOM INFLUENZA A & B TEST | PSZ | Substantially Equivalent | |
| K053066 | SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH | FTL | Substantially Equivalent | |
| K043035 | SEPRAGEL ENT BIORESORBABLE PACKING/STENT | KHJ | Substantially Equivalent | |
| K040241 | N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET | DCK | Substantially Equivalent | |
| K040868 | SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH | FTM | Substantially Equivalent | |
| K033864 | GENZYME OSOM TRICHOMONAS RAPID TEST | JWZ | Substantially Equivalent | |
| K023544 | GENZYME CONTRAST II HCG URINE/SERUM TEST | JHI | Substantially Equivalent | |
| K021316 | ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR | LBS | Substantially Equivalent | |
| K021019 | COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE | GAT | Substantially Equivalent | |
| K012532 | SEPRAGEL SINUS | LYA | Substantially Equivalent | |
| K011843 | GENZYME DIRECT-AMYLASE TEST REAGENT | JFJ | Substantially Equivalent | |
| K000239 | GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL | LCP | Substantially Equivalent | |
| K994328 | SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX | FTL | Substantially Equivalent | |
| K992766 | N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET | MRR | Substantially Equivalent | |
| K993132 | GENZYME DIRECT AMYLASE VERIFIER | JIT | Substantially Equivalent | |
| K983726 | GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL | LCP | Substantially Equivalent | |
| K971573 | N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET | LBR | Substantially Equivalent | |
| K971190 | N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR | LBS | Substantially Equivalent | |
| K971162 | LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR | LBS | Substantially Equivalent | |
| K962186 | N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR | LBR | Substantially Equivalent | |
| K954898 | PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) | GGT | Substantially Equivalent | |
| K943150 | DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT | MRR | Substantially Equivalent | |
| K933397 | GENZYME A-AMYLASE TEST REAGENT | JFJ | Substantially Equivalent | |
| K926390 | PREDICTA ERYTHROPOIETIN KIT | GGT | Substantially Equivalent | |
| K924674 | DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT | MRR | Substantially Equivalent | |
| K921057 | AMYLASE REAGENT | JFJ | Substantially Equivalent | |
| K912519 | AMYLASE REAGENT | JFJ | Substantially Equivalent | |
| K911406 | HDL CHOLESTEROL REAGENT | LBR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1220423 | 1220423 | GENZYME CORPORATION | 76 NEW YORK AVENUE, FRAMINGHAM, MA 01701 US | 2026 | |
| 3039908023 | 3039908023 | GENZYME CORPORATION | 1125 PLEASANTVIEW TERRACE, Ridgefield, NJ 07657 US | 2026 | |
| 1226230 | 3002836339 | Vericel Corporation | 64 Sidney St, CAMBRIDGE, MA 02139 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NBHAccessories, Arthroscopic
- MOZAcid, Hyaluronic, Intraarticular
- GGTAssay, Erythropoietin
- LCPAssay, Glycosylated Hemoglobin
- MCNBarrier, Absorbable, Adhesion
- PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JITCalibrator, Secondary
- JFJCatalytic Methods, Amylase
- NNKContainer, Specimen Mailer And Storage, Non-Sterile
- KDWContainer, Specimen Mailer And Storage, Temperature Controlled, Sterile
- OCECultured Epithelial Autograft
- FZTCutter, Surgical
- PSZDevices Detecting Influenza A, B, And C Virus Antigens
- KDCInstrument, Surgical, Disposable
- JWZKit, Screening, Trichomonas
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- LBRLdl & Vldl Precipitation, Hdl
- KITMedia And Components, Synthetic Cell And Tissue Culture
- FTMMesh, Surgical
- FTLMesh, Surgical, Polymeric
- OBCOccluder, Internal Vessel, Temporary
- HWQPasser
- KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
- LLHReagents, Clostridium Difficile Toxin
- NBESealant, Polymerizing
- LYASplint, Intranasal Septal
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- MRRSystem, Test, Low Density, Lipoprotein
- HXGTamp
- FTYTape, Measuring, Rulers And Calipers
- NDYTest, Cystatin C
- FSMTray, Surgical, Instrument
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1856-2012 | seprafilm Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder. | Sterility of product may be compromised due to packaging defect | Class II | Terminated | |
| Z-1855-2012 | seprafilm Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder. | Sterility of product may be compromised due to packaging defect | Class II | Terminated | |
| Z-2310-2010 | Genzyme Biosurgery Essentials Kit, Item Number 82004 | Revised Labeling of Carticel Essentials Kit clarifies the non-sterile packaging of the outer clear plastic tray which should not be opened in the sterile field. | Terminated | ||
| Z-2151-2008 | Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-E For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 . | Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits. | Terminated | ||
| Z-2150-2008 | Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-D For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 . | Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits. | Terminated | ||
| Z-2149-2008 | Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-C For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 . | Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits. | Terminated | ||
| Z-2148-2008 | Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-B For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 80-2005-01. | Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits. | Terminated | ||
| Z-1648-2008 | Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier). Japan Distribution Only Product Number: 4301-05 | Sterility may be compromised | Terminated | ||
| Z-1647-2008 | Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier) Product Number: 4301-02 | Sterility may be compromised | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain