Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·HYDRELLE

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·Straumann Emdogain

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System for Bowel Control

Stent, Iliac Vein

FDA Pre-Market Approval

FDA Class 3 ·VICI VENOUS STENT System

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis with and without InhibiZone

Ventricular (Assist) Bypass

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Hepatitis B core IgM (aHBcM) Assay

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·MENICON SF-P (MELAFOCON A) CONTACT LENS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP.

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV HR ASSAY

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Avitene Microfibrillar Collagen Hemostat (MCH)

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC IGM ASSAY

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESES WITH INHIBIIZONE TREATMENT; AMBICOR INFLATABLE PENILE PROSTHESES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BARD ABLATION SYSTEM

Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

FDA Pre-Market Approval

FDA Class 3 ·RESQCPR SYSTEM

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·Orthovisc

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Avitene Microfibrillar Collagen Hemostat

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP System

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·ENTERYX PROCEDURE KIT, MODEL M000572600