Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·Falope Ring Bands

Over-The-Counter Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·HeartStart OnSite Defibrillator and HeartStart Home Defibrillator

Stent, Urethral, Prostatic, Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·SPANNER TEMPORARY PROSTATIC STENT WITH DISTAL CURVE DESIGN CHANGE

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Reherniation Reduction Device

FDA Pre-Market Approval

FDA Class 3 ·Barricaid® Annular Closure Device

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC EIA

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS MODEL 800 ARTIFICIAL URINARY SPHINCTER

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·CHARITE ARTIFICIAL DISC

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK Automated External Defibrillators (AEDs)

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APILGRAF

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (with and without Inhibizone Treatment)

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4

Spinal Pedicle Screw, Fixation, Appliance System

FDA Pre-Market Approval

FDA Class 3 ·LUMBAR I/F CAGE SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·CODMAN 3000 SERIES CONSTANT-FLOW IMPLANTABLE INFUSION PUMP, MEDSTREAM REFILL KITS, SURESTREAM INTRASPINAL CATHETER KIT,C

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000(R) BI-VENTRICULAR SUPPORT SYSTEM