Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Hepatitis B orfe IgM (aHBcM) Assay

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·EluNIR TM Ridaforolimus Eluting Coronary Stent System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·OVATIO VR/DR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY SR 2250, SYMPHONY DR 2550, RHAPSODY SR 2210, RHAPSODY DR 2510, RHAPSODY DR 2530, REPLY ST & REPLY DR PACEMAKERS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·OVATIO CRT

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM IN VITRO DIAGNOSTIC DEVICE

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA Pre-Market Approval

FDA Class 3 ·BIOTRIN INTERNATIONALS PARVOVIRUS B19 IGG IN VITRO DIAGNOSTIC DEVICE

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC CRT-D & CONCERTO/CONSULTA CRT-D/MAXIMO II CRT-D & VARIOUS INSYNC FAMILES ODF ICDS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·SmartAblate System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ENERGEN IMPLANTABLE CARD

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, INCEPTA CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, ENERGEN

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip System (NT)

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·LUTONIX DRUG COATED BALLOON (DCB)

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·CARDIOCOMMAND ESOPHAGEAL BIPOLAR PACING & RECORDING CATHETERS

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·ASSURE Wearable Cardioverter Defibrillator (WCD) System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM