Genzyme Corp.
Medical device manufacturer in Framingham, MA.
33510(k) clearances
2PMA approvals
9recalls
Device types
- JFJ Catalytic Methods, Amylase 4
- MRR System, Test, Low Density, Lipoprotein 3
- LBS Ldl & Vldl Precipitation, Cholesterol Via… 3
- LBR Ldl & Vldl Precipitation, Hdl 3
- FTL Mesh, Surgical, Polymeric 3
- PSZ Devices Detecting Influenza A, B, And C… 3
- GGT Assay, Erythropoietin 2
- LCP Assay, Glycosylated Hemoglobin 2
- LLH Reagents, Clostridium Difficile Toxin 1
- NDY Test, Cystatin C 1
- KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or… 1
- DCK C-Reactive Protein, Antigen, Antiserum, And… 1
- FTM Mesh, Surgical 1
- JWZ Kit, Screening, Trichomonas 1
- JHI Visual, Pregnancy Hcg, Prescription Use 1
- GAT Suture, Nonabsorbable, Synthetic… 1
- LYA Splint, Intranasal Septal 1
- JIT Calibrator, Secondary 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K102242 | Osom C. Difficile Toxin A/B TestLLH · Traditional | 12/21/2010SE |
| K092633 | Osom Influenza A&B Test , Model PN190PSZ · Special | 09/25/2009SE |
| K080662 | Genzyme Cystatin C Reagent Anf Genzyme Cystatin C CalibratorNDY · Traditional | 05/15/2008SE |
| K063739 | Sepramesh, Model 5959-1214FTL · Traditional | 01/17/2007SE |
| K061508 | Osom Influenza A&B TestPSZ · Traditional | 06/12/2006SE |
| K051244 | Genzyme Osom Influenza a & B TestPSZ · Traditional | 02/21/2006SE |
| K053066 | Sepramesh Ip Bioresorbable Coating/Permanent MeshFTL · Traditional | 12/19/2005SE |
| K043035 | Sepragel ENT Bioresorbable Packing/StentKHJ · Traditional | 07/11/2005SE |
| K040241 | N-Geneous Wide Range CRP Reagent and Calibrator SetDCK · Traditional | 06/25/2004SE |
| K040868 | Sepramesh Ip Bioresorbable Barrier - Permanent MeshFTM · Traditional | 06/04/2004SE |
| K033864 | Genzyme Osom Trichomonas Rapid TestJWZ · Traditional | 04/02/2004SE |
| K023544 | Genzyme Contrast II HCG Urine/Serum TestJHI · Traditional | 01/16/2003SE |
| K021316 | Ultra N-Geneous HDL Cholesterol Reagent 1/REAGENT2; Ultra N-Geneous HDL Cholestreol…LBS · Traditional | 07/25/2002SE |
| K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester SutureGAT · Traditional | 06/18/2002SE |
| K012532 | Sepragel SinusLYA · Traditional | 10/30/2001SE |
| K011843 | Genzyme Direct-Amylase Test ReagentJFJ · Traditional | 08/10/2001SE |
| K000239 | Glypro Reagent, Glypro Calibrator, Glypro Low Control, Glypro High ControlLCP · Traditional | 03/21/2000SE |
| K994328 | Sepramesh Biosurgical Composite, Model Smbc-XxxFTL · Traditional | 03/02/2000SE |
| K992766 | N-Geneous Ldl-St Cholesterol Reagent, N-Geneous Ldl-St Cholesterol Calibrator, Genzyme…MRR · Traditional | 10/18/1999SE |
| K993132 | Genzyme Direct Amylase VerifierJIT · Abbreviated | 10/04/1999SE |
| K983726 | Glypro Reagent, Glypro Calibrator, Glypro Low Control, Glypro High ControlLCP · Traditional | 11/25/1998SE |
| K971573 | N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator, Genzyme LDL…LBR · Traditional | 06/18/1997SE |
| K971190 | N-Geneous HDL Cholesterol Kit/Cholesterol CalibratorLBS · Traditional | 06/16/1997SE |
| K971162 | Liquid N-Geneous HDL Cholesterol Kit/CalibratorLBS · Traditional | 06/16/1997SE |
| K962186 | N-Geneous HDL Cholesterol Kit/Cholesterol CalibratorLBR · Traditional | 08/19/1996SE |
| K954898 | Predicta Erythropoietin Kit (Modification)GGT · Traditional | 02/05/1996SE |
| K943150 | Direct LDL Cholesterol Immunoseparation Reagent KitMRR · Traditional | 03/15/1995SE |
| K933397 | Genzyme A-Amylase Test ReagentJFJ · Traditional | 10/28/1993SE |
| K926390 | Predicta Erythropoietin KitGGT · Traditional | 06/25/1993SE |
| K924674 | Direct LDL Choles Immunoseparation ReagentMRR · Traditional | 01/06/1993SE |
| K921057 | Amylase ReagentJFJ · Traditional | 03/27/1992SE |
| K912519 | Amylase ReagentJFJ · Traditional | 07/01/1991SE |
| K911406 | HDL Cholesterol ReagentLBR · Traditional | 05/22/1991SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1856-2012 Class II | seprafilm Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm…Sterility of product may be compromised due to packaging defect | 06/13/2012Terminated |
| Z-1855-2012 Class II | seprafilm Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage:…Sterility of product may be compromised due to packaging defect | 06/13/2012Terminated |
| Z-2310-2010 | Genzyme Biosurgery Essentials Kit, Item Number 82004Revised Labeling of Carticel Essentials Kit clarifies the non-sterile packaging of the outer clear plastic… | 07/13/2010Terminated |
| Z-2151-2008 | Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-E For In Vitro Diagnostic…Calibration and Quality Control outside of established range resulting from an increase in initial OD… | 04/14/2008Terminated |
| Z-2150-2008 | Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-D For In Vitro Diagnostic…Calibration and Quality Control outside of established range resulting from an increase in initial OD… | 04/14/2008Terminated |
| Z-2149-2008 | Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-C For In Vitro Diagnostic…Calibration and Quality Control outside of established range resulting from an increase in initial OD… | 04/14/2008Terminated |
| Z-2148-2008 | Equal Diagnostics Lipase Color Reagent Kit Part Number: 905-B For In Vitro Diagnostic…Calibration and Quality Control outside of established range resulting from an increase in initial OD… | 04/14/2008Terminated |
| Z-1648-2008 | Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose…Sterility may be compromised | 04/10/2008Terminated |
| Z-1647-2008 | Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose…Sterility may be compromised | 04/10/2008Terminated |