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Establishment Registration & Device Listing

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1 to 5 of 17 Results for Product Code : LWQ

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Establishment
Name

Registration Number

Current
Registration Yr

PR/USA

2648612

2026

heart-valve, mechanical - Masters Series™ Aortic Valved Graft with Hemashield Graft Technology (CAVGJ); Masters Series™ HP Valved Graft with Gelweave Valsalva Technology (VAVGJ); Masters Series™ Mechanical Heart Valve (Aortic); Masters Series™ Mechanical Heart Valve (Mitral); Masters Series™ Mechanical Heart Valve with Expanded Hemodynamic Plus (HP) Sewing Cuff (Aortic); Masters Series™ Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Aortic); Masters Series™ Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Mitral); Masters Series™ Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Aortic); Masters Series™ Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Mitral); Masters Series™ Mechanical Heart Valve with PTFE Sewing Cuff (Aortic); Masters Series™ Mechanical Heart Valve with PTFE Sewing Cuff (Mitral); Regent™ Mechanical Heart Valve; Regent™ Mechanical Heart Valve (FlexCuff™); SJM™ Masters Series Mechanical Heart Valve; SJM™ Masters Series Mechanical Heart Valve Aortic Expanded PTFE Cuff; SJM™ Masters Series Mechanical Heart Valve Mitral Expanded Hemodynamic Plus (HP)

Manufacturer

PR/USA

3006705815

2026

heart-valve, mechanical - Masters Series™ Aortic Valved Graft with Hemashield Graft Technology (CAVGJ); Masters Series™ HP Valved Graft with Gelweave Valsalva Technology (VAVGJ); Masters Series™ Mechanical Heart Valve (Aortic); Masters Series™ Mechanical Heart Valve (Mitral); Masters Series™ Mechanical Heart Valve with Expanded Hemodynamic Plus (HP) Sewing Cuff (Aortic); Masters Series™ Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Aortic); Masters Series™ Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Mitral); Masters Series™ Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Aortic); Masters Series™ Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Mitral); Masters Series™ Mechanical Heart Valve with PTFE Sewing Cuff (Aortic); Masters Series™ Mechanical Heart Valve with PTFE Sewing Cuff (Mitral); Regent™ Mechanical Heart Valve; Regent™ Mechanical Heart Valve (FlexCuff™); SJM™ Masters Series Mechanical Heart Valve; SJM™ Masters Series Mechanical Heart Valve Aortic Expanded PTFE Cuff; SJM™ Masters Series Mechanical Heart Valve Mitral Expanded Hemodynamic Plus (HP)

Contract Sterilizer

MN/USA

3007113487

2026

heart-valve, mechanical - Epic™ Max Valve (Aortic); Epic™ Plus Supra Valve (Aortic); Epic™ Plus Valve (Aortic); Epic™ Plus Valve (Mitral); Epic™ Supra Valve (Aortic); Epic™ Valve (Aortic); Epic™ Valve (Mitral)

Manufacturer

heart-valve, mechanical - Trifecta Bioprosthetic Heart Valve; Trifecta Valve with Glide Technology (Trifecta GT)

Specification Developer

heart-valve, mechanical - Masters Series™ Aortic Valved Graft with Hemashield Graft Technology (CAVGJ); Masters Series™ HP Valved Graft with Gelweave Valsalva Technology (VAVGJ); Masters Series™ Mechanical Heart Valve (Aortic); Masters Series™ Mechanical Heart Valve (Mitral); Masters Series™ Mechanical Heart Valve with Expanded Hemodynamic Plus (HP) Sewing Cuff (Aortic); Masters Series™ Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Aortic); Masters Series™ Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Mitral); Masters Series™ Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Aortic); Masters Series™ Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Mitral); Masters Series™ Mechanical Heart Valve with PTFE Sewing Cuff (Aortic); Masters Series™ Mechanical Heart Valve with PTFE Sewing Cuff (Mitral); Regent™ Mechanical Heart Valve; Regent™ Mechanical Heart Valve (FlexCuff™); SJM™ Masters Series Mechanical Heart Valve; SJM™ Masters Series Mechanical Heart Valve Aortic Expanded PTFE Cuff; SJM™ Masters Series Mechanical Heart Valve Mitral Expanded Hemodynamic Plus (HP)

Manufacturer

MN/USA

2135147

2026

heart-valve, mechanical - Masters Series™ Aortic Valved Graft with Hemashield Graft Technology (CAVGJ); Masters Series™ HP Valved Graft with Gelweave Valsalva Technology (VAVGJ); Masters Series™ Mechanical Heart Valve (Aortic); Masters Series™ Mechanical Heart Valve (Mitral); Masters Series™ Mechanical Heart Valve with Expanded Hemodynamic Plus (HP) Sewing Cuff (Aortic); Masters Series™ Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Aortic); Masters Series™ Mechanical Heart Valve with Expanded Polyester Sewing Cuff (Mitral); Masters Series™ Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Aortic); Masters Series™ Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff (Mitral); Masters Series™ Mechanical Heart Valve with PTFE Sewing Cuff (Aortic); Masters Series™ Mechanical Heart Valve with PTFE Sewing Cuff (Mitral); Regent™ Mechanical Heart Valve; Regent™ Mechanical Heart Valve (FlexCuff™); SJM™ Masters Series Mechanical Heart Valve; SJM™ Masters Series Mechanical Heart Valve Aortic Expanded PTFE Cuff; SJM™ Masters Series Mechanical Heart Valve Mitral Expanded Hemodynamic Plus (HP)

Complaint File Establishment

heart-valve, mechanical - Trifecta Bioprosthetic Heart Valve; Trifecta Valve with Glide Technology (Trifecta GT)

Complaint File Establishment

heart-valve, mechanical - Epic™ Max Valve (Aortic); Epic™ Plus Supra Valve (Aortic); Epic™ Plus Valve (Aortic); Epic™ Plus Valve (Mitral); Epic™ Supra Valve (Aortic); Epic™ Valve (Aortic); Epic™ Valve (Mitral)

Complaint File Establishment

Abbott Medical Costa Rica Limitada (Structural Heart)

COSTA RICA

3014918977

2026

heart-valve, mechanical - Epic™ Max Valve (Aortic); Epic™ Plus Supra Valve (Aortic); Epic™ Plus Valve (Aortic); Epic™ Plus Valve (Mitral); Epic™ Supra Valve (Aortic); Epic™ Valve (Aortic); Epic™ Valve (Mitral)

Manufacturer

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