Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject® W Trabecular Micro-Bypass System

Tympanostomy Tube Delivery Product With Drug

FDA Pre-Market Approval

FDA Class 3 ·Tula SystemTube Delivery System (TDS)

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD/CD2, RENEWAL

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD 2 MODEL H115

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·CDS II (SODIUM CHONDROITIN SULFATE)

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD/CD2/RENEWAL/EASYTRAK

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject® W Trabecular Micro-Bypass System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD/CD2/RENEWAL /RENEWAL 3

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD 2 CRT-D SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX/ MINI/ CONTAK CD & CD2

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL/CD 2/RENEWAL RF FAMILIES

PD-1400 PACER/DEFIBRILLATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD2, CONTAK RENEWAL/RENEWAL 3/ RENEWAL 3/3HE RF

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

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD 2, CONTAK RENEWAL 3 DS, CONTAK RENEWAL 3 HE

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD, CONTAK CD 2, EASYTRAK, CONTAK RENEWAL, CONTAK RENEWAL 3

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD 2 (MODELS H115, H119) AND APPLICATION SOFTWARE MODEL 2844

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRISM/PRIZM 2/ CONTAK CD2/VITALITY DS/EL MODEL 2844 VERSION 3.8

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD, CONTAK CD2, EASYTRAK, EASYTRAK 2, EASYTRAK 3, CONTAK RENEWAL, CONTAK RENEWAL 3