Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK MODIFIED ORIFICE (MO) VALUED CONDUIT

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS

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

FDA Pre-Market Approval

FDA Class 3 ·PATH VYSION HER-2 DNA PROBE KIT ASSAY

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·SOLESTA

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS MODELS 995/995CS/995MS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·GELFOAM PLUS HEMOSTATS KITS

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·Vysis ALK Break Apart Fish Probe Kit

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT,PROBECHEK ALK POSITIVE CONTROL SLIDES KIT,PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Mosaic 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 (MO) VALVED CONDUIT

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HR HPV Assay

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Bioprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS

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 BIOPROSTHESIS, MODELS T505 AND T510

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Gelfoam (absorbable gelatin) Sterile Sponge