Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval

FDA Class 3 ·FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,

Absorbable Collagen Hemostatic Agent With Thrombin

FDA classification

FDA Class 3 ·Absorbable Collagen Hemostatic Agent With Thrombin

Adhesive, Denture, Karaya With Sodium Borate

FDA classification

FDA Class 3 ·Adhesive, Denture, Karaya With Sodium Borate

Tympanostomy Tube Delivery Product With Drug

FDA classification

FDA Class 3 ·Tympanostomy Tube Delivery Product With Drug

Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy

FDA classification

FDA Class 3 ·Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy

Bone Grafting Material, Dental, With Biologic Component

FDA classification

FDA Class 3 ·Bone Grafting Material, Dental, With Biologic Component

Implant, Dermal, For Aesthetic Use In The Hands

FDA classification

FDA Class 3 ·Implant, Dermal, For Aesthetic Use In The Hands

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA classification

FDA Class 3 ·Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

FDA classification

FDA Class 3 ·Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

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

FDA classification

FDA Class 3 ·Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA classification

FDA Class 3 ·Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA classification

FDA Class 3 ·Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

FDA classification

FDA Class 3 ·Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator

FDA classification

FDA Class 3 ·Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator

Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight

FDA classification

FDA Class 3 ·Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA classification

FDA Class 3 ·Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA classification

FDA Class 3 ·Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA classification

FDA Class 3 ·Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator

FDA classification

FDA Class 3 ·Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator