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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESES (IPP)

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella Ventricular Support Systems

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Intera 3000 Hepatic Artery Infusion Pump

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA 5.0 System

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 ·Powerheart® G3, G3 Plus and G5 AEDs

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

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

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

Stent, Urethral, Prostatic, Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·THE SPANNER TEMPORARY PROSTATIC STENT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur (XP/XPT, CP) AFP; Atellica IM AFP

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·Envision Mammography Platform

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·EMODOGAIN

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·HYDRELLE

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

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

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·Synvisc, Synvisc-One

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

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

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEM (AUS)