Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SYNVISC-ONE

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Artificial Urinary Sphincter

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, CP, and CP with SmartAssist

Ventricular (Assist) Bypass

FDA Pre-Market Approval

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

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB & ENDOAVITENE

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·MONOPREP PAP TEST

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF (GRAFTSKIN)

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·MONOPREP PAP TEST

Implanted Fecal Incontinence Device

FDA Pre-Market Approval

FDA Class 3 ·ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION WITH QWIK LOAD

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, and Impella LD Systems

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System™ (OCS) Lung System

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·Monovisc

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Ophthalmic Viscoelastic

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·EMDOGAIN

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR XP SOFTWARE V6.0 ANTI-HBS

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS) Heart