Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (3% Sodium Hyaluronate)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·SMARTVIEW REMOTE MONITORING SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ELITE, ELITE II, MINUET, PREVA, PREVA D, PRODIGY, SYNERGYST II, THERA, THERA-I, ANALYZER, VITATRON LEGACY, VITATRON

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·TACTICATH QUARTZ SET

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ENRHYTHM

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ENRHYTHM IPG

Neuromodulator For Obesity

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO RECHARGEABLE SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) HALL PROSTHETIC HEART VALVE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE PACEMAKER

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Supera Peripheral Stent System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Lyft with Lidocaine Cannula Injection

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·SenTiva Model 1000 and SenTiva Duo Model 1000-D 2024 Generator Firmware Maintenance

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL)

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

FDA Pre-Market Approval

FDA Class 3 ·BELOS/LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER VSD MUSCULAR OCCLUDER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, ORIGEN EL ICD, ORIGEN MINI ICD