Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CYROABLATION THERAPY SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL HEMOSTATIC PUNCTURE CLOSURE DEVICE

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate 4000 System Type-1 (i.e. Type 1.0/1.1)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Reply SR, Reply Dr, Esprit SR, Esprit DR (2nd generation , i.e. V2 ) & (5TH generation i.e.V5)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE®1 EXCLUDER® AAA Endoprosthesis (AAA), GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·AMVISC & AMVISC PLUS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·INSPIRE UPPER AIRWAY STIMULATION THERAPY SYSTEM

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·MagtraceTM and Sentimag(R) Magnetic Locatization System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RESTYLANE/PERLANE/RESTYLANE-L/PERLANE-L INJECTABLE GELS

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·PROSTATRON

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS PRESCRIPTION INSERTS

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS PRESCRIPTION INSERTS

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS® Corneal Implants

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·KAMRA INLAY

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·KAMRA INLAY