Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·LOTUS Edge Valve System

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SYNVISC & SYNVISC-ONE

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·ARTEGRAFT{TM} AND REINFORCED ARTEGRAFT{TM}

Reherniation Reduction Device

FDA Pre-Market Approval

FDA Class 3 ·BARRICAID ANULAR CLOSURE DEVICE (ACD)

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PROSORBA(TM) COLUMN

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

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

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD

Implanted Fecal Incontinence Device

FDA Pre-Market Approval

FDA Class 3 ·ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD and Impella 5.5 with SmartAssist Systems

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE DRUG DELIVERY SYSTEM

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

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

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·X Series/Propaq MD

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Alpha Fetoprotein (AFP) Assay

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED Plus

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

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Anti-Hepatitis B core Total (HBcT) Assay

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella CP with SmartAssist

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Urinary Control System with and without InhibiZone