Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·LOTUS Edge Valve System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED Plus and Fully Automatic AED Plus

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·BLU-U Blue Light Photodynamic Therapy Illuminator

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·CPR Uni-padz III

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA IMS COMPLEXED PROSTATE SPECIFIC ANTIGEN ASSAY (CPSA)

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·TMX-2000 BPH THERMOTHERAPY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

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

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·FALOPE-RING(R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM

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

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 Series Product Line/Artificial Urinary Sphincter with and without InhibiZone Treatment

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 SERIES INFLATABLE PENILE PROSTHESES

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (FICDx)

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·Synvisc, Synvisc-One

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Intera 3000 Hepatic Artery Infusion Pump

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Powerheart G5 AED

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800™ Artificial Urinary Sphincter, AMS 800™ Artificial Urinary Sphincter with InhibiZone™

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·CHARITE ARTIFICIAL DISC

Implanted Fecal Incontinence Device

FDA Pre-Market Approval

FDA Class 3 ·ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER