Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella CP with SmartAssist

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH)

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700™ Inflatable Penile Prosthesis (IPP

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED Plus and Fully Automatic AED Plus

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM, NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL SYSTEM WITH SURE

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS SPHINCTER 800 URINARY CONTROL SYSTEM

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED Plus

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5 System and Impella Ventricular Support Sustems

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·INFUSAID REFILL KIT

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·SYNVISC (HYLAN G-F 20)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP ACCESSORIES, MEDSTREAM PROGRAMMABLE INFUSION SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·STAARVISC II AND SHELLGEL SODIUM HYALURONATE

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Prostate-Specific Antigen (PSA) Assay

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS SPHINCTER 800 URINARY PROSTHESIS