Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS PCUB-32D0 AND PCUB-53D0

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS PCUB-30SEO AND PCUB-32SEO IOL

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·Magtrace and Sentimag Magnetic Locatization System (PUV)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INCEPTA,ENERGEN,PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATORS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INCEPTA,ENERGEN,PUNCTUA,TELIGEN IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATORS

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·Magtrace® and Sentimag® Magnetic Locatization System (PUV)

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·Magtrace® and Sentimag® Magnetic Locatization System (PUV)

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS HF SYSTEM

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·digene HC2 High-Risk HPV DNA Test and digene HC2 HPV DNA Test

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System pump rotor sub-assembly

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·THE BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM, THE BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATO

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus® 24 Cochlear Implant System

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MynxGrip, Mynx Ace, and Mynx Control Vascular Closure Device (VCD)

Agent, Injectable, Embolic

FDA Pre-Market Approval

FDA Class 3 ·Apollo Onyx Delivery Micro Catheter, 1.5cm, Straight/Apollo Onyx Delivery Micro Catheter, 3.0cm, Straight

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK® 35 Monitor/Defibrillator

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·CentriMag™ Circulatory Support System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Certitude Introducer Sheath Set

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS COCHLEAR IMPLANT SYSTEM