Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN, INOGEN, DYNAGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ORIGEN, INOGEN, DYNAGEN, CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CSI CONTACT LENS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NovaSure Impedance Controlled Endometrial Ablation System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CSI(CROFILCON A)EXTENDED WEAR SOFT

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE IS-I PASSIVE FIXATION

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CSI (CROFILCON A) EXTENDED WEAR SOFT

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Interga Omnigraft Dermal Regenerat

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Prospera SCS System, Resilience Percutaneous Lead, Embrace One, TrueLock

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Diamondback 360 Coronary Orbital Atherectomy Device (OAD)

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·VENTANA HER2 Dual ISI-I DNA Probe Cocktail

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·OL1000, OL1000 SC, SPINALOGIC

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASOSEAL (VASCULAR HEMOSTASIS DEVICE)

Solution, Cleaning / Lubricating, Artificial Eye

FDA Pre-Market Approval

FDA Class 3 ·ENUCLENE CLEANING/LUBRICATING SOLUTION

Ultrasound, Hyperthermia, Cancer Treatment

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEM

Solution, Cleaning / Lubricating, Artificial Eye

FDA Pre-Market Approval

FDA Class 3 ·ENUCLENE(R) OPHTHALMIC SOLUTION

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO, RIGHT VENTRICULAR LEAD INTEGRITY ALERT, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC UCD, INSYNC II MARQUIS, INSY

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

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO, RIGHT VENTRICULAR LEAD INTEGRITY ALERT, CONCERTO-II CRT-D, CONSULTA CRT-D, INSYNC ICD, INSYNC II MARQUIS, INSY