Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·OG(R) CARDIAC PACING SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML, DGR,INC.

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spinal Cord Stimulator (SCS) Systems, (Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montag

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Deep Brain Stimulation (DBS) Systems (Vercise, Vercise PC, and Vercise Gevia)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MIRCO-DRIVER OVER-THE -WIRE(OTW) CORONARY STENT SYSTEM & MX2 CORONARY STENT SYSTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·USE OF RED PLASTIC PLUG WITH CONCEPT -1 SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·USE OF RED PLASTIC PLUG WITH CONCEPT -1 SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·USE OF RED PLASTIC PLUG WITH CONCEPT -1 SOLUTION

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

FDA Pre-Market Approval

FDA Class 3 ·NEW JERSEY LCS(R) TOTAL KNEE SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·HV Splitter/Adaptor kit (5019); Sprint Quattro Lead (6947M); Sprint Quattro Lead (6946M); Sprint Quattro Lead (6935M)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Epsila EV Extravascular Lead (EV2401)

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·MAGNISCAN 5000 MRI SYSTEM

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·MAGNISCAN 5000 MRI SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETER

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Prometra Programmable Infusion Pump System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·BOSTON SCINTIFIC SCIMED PTCA CATHETER