2,770 results · 20ms · Sources: EU EUDAMED, US FDA

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DEFLUX INJECTABLE GEL

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·PORCINE BIOPROSTHESIS MODELS 305, 310

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·MOSAIC PORCINE (MODEL 305) AND HANCOCK II (MODEL T505) BIOPROSTHESES

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·GELFOAM STERILE POWDER

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval
FDA Class 3 ·OXFORD PARTIAL KNEE

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock II Bioprosthesis, Ultra Bioprosthesis

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT, MODELS 105 AND 150

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Abbott RealTime IDH1

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS, MODELS 305, 310

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·(Gelfoam (absorbable gelatin) Sterile Sponge)

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Bioprosthesis

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Hancock Modified Orifice Valved Conduit

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·DEFLUX INJECTABLE GEL

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK MODIFIED ORIFICE VALVED CONDUIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Abbott RealTime IDH1 Assay