Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Mosaic Bioprosthesis, Models 305 and 310

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock II Bioprosthesis, Models T505 and T510

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC HALL PROSTHETIC HEART VALVE, AORTIC VALVED CONDUIT, AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK 1 STANDARD BIOPROSTHETIC VALVE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK MODIFIED ORIFICE, MODIFIED ORIFICE II AORTIC BIOPROSTHESES

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas KRAS Mutation Test /Roche cobas DNA Sample Preparation Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas EGFR Mutation Test, Roche cobas DNA Sample Preparation Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas EGFR Mutation Test / Roche cobas DNA Sample Preparation Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·ROCHE COBAS EGFR MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas KRAS Mutation Test, Roche cobas DNA Sample Preparation Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas DNA Sample Preparation Kit, COBAS 4800 BRAF V600 MUTATION TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Cobas EGFR Mutation Test v2, Cobas DNA and cfDNA Sample Preparation Kit

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas DNA Sample Preparation Kit / Roche cobas 4800 BRAF V600 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas DNA Sample Preparation Kit, Roche cobas 4800 BRAF V600 Mutation Test