Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·SJM EPIC VALVE AND SJM EPIC SUPRA VALVE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LINOX TD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ENPULSE INPLANTABLE PULSE GENERATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ENPULSE IMPLANTABLE PULSE GENERATOR AND MODEL 9991 APPLICATION SOFTWARE

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV HR HIGH-THROUGHPUT AUTOMATION

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 28-8 pharmDx

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·COLOGUARD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LINOX S & LINOX T IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SULZER CARBOMEDICS CARBO-SEAL ASCENDING AORTIC PROSTHESIS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·BIO RAD MONOLISA ANTI-HBC IGM EIA

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ATS OPEN PIVOT BILEAFLET AORTIC VALVED GRAFT

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HARMONY HIRESOLUTION BIONIC EAR SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS (POLYMACON) CONTACT LENSES

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBS EIA

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·TALENT PULSE GENERATOR MODELS DR233 AND SR 133 AND PROGRAMMER SOFTWARE CSO 4.18 UG

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG