2,770 results · 25ms · Sources: EU EUDAMED, US FDA

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval
FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

Heart-Valve, Non-Allograft Tissue

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

Agent, Bulking, Injectable For Gastro-Urology Use

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

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·Solesta Injectable Gel

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

FDA Pre-Market Approval
FDA Class 3 ·OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·ABBOTT REALTIME HBV ASSAY

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 ·HANCOCK II BIOPROSTHETIC HEART VALVE

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Mosaic Bioprosthesis

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK MODIFIED ORIFICE BIOPROSTHESIS

Heart-Valve, Non-Allograft Tissue

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

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Abbott RealTime IDH1, Abbott RealTime IDH1 Amplification Reagent Kit, Abbott RealTime IDH1 Control Kit, Abbott RealTime

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 ·HANCOCK II PORCINE BIOPROSTHESIS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK I LOW POROSITY & MODIFIED ORIFICE VALVED CONDUIT MODEL 150

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

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

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Mosaic Bioprosthesis

Replacement Heart-Valve

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

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·GELFOAM PLUS HEMOSTASIS KIT

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS