Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Itrel, Synergy and Intellis, Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Le

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System and Ascenda Intrathecal Catheters

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH EPIDURAL/PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS2 OTW CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·LIBERTE OTW CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS2 OTW PACLITAXEL ELUTING STENT SYSTEM

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

System, Rf/Microwave Hyperthermia, Cancer Treatment

FDA Pre-Market Approval

FDA Class 3 ·CLINI-THERM MARK I/IV/ DIPOLE ARRAY APPLICATOR

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-MAK-2 PLUS, HBsAg Confirmatory Test Assays

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

FDA Pre-Market Approval

FDA Class 3 ·Allure RF, Allure Quadra RF, Allure Quadra, Allure, Quadra Allure MP,Quadra Allure MP RF

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity, Assurity +, Endurity, Endurity Core

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROPACE RNS SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ellipse VR, Ellipse DR, Fortify, Fortify Assura

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

FDA Pre-Market Approval

FDA Class 3 ·Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP