Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-EBK PLUS ASSAY

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS ASSAY

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-EBK PLUS ASSAY

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-COREK PLUS

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-AB-AUK PLUS ASSAY

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·REZOOM MULTIFOCAL IOLS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Subcutaneous Implantable Cardioverter Defibrillator

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens

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

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN CRT-D, ORIGEN X4 CRT-D, MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL DR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCOLAD

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Orsiro Mission Sirolimus Eluting Coronary Stent System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SICD Gen 2, SICD MRI

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, VISIONIST X4 CRT-P

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

FDA Pre-Market Approval

FDA Class 3 ·ST JUDES MEDICAL ICDS AND CRT-DS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT DS DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER