Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE TREATMENT

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·ZOLL AED Plus and ZOLL Fully Automatic AED Plus

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP Flex with SmartAssist and Impella RP with SmartAssist

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·ELEVESS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·HeartLight Endoscopic Ablation System

Spinal Pedicle Screw, Fixation, Appliance System

FDA Pre-Market Approval

FDA Class 3 ·LUMBAR I/F CAGE WITH VSP SPINE SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR AHBCM ASSAY

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

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Complexed PSA (cPSA) Assay

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS SPHINCTER 800 URINARY CONTROL SYSTEM

Implanted Fecal Incontinence Device

FDA Pre-Market Approval

FDA Class 3 ·AMS ACTICO N NEOSPHINCTER

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·Straumann Emdogain

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·MONOVISC

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM/ ABLATION SYSTEM WITH SURESOUND UTERINE SOUND

Implanted Fecal Incontinence Device

FDA Pre-Market Approval

FDA Class 3 ·AMS ACTICON NEOSPHINCTER

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella CP with SmartAssist, Impella 5.5 with SmartAssist

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBCIGM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Lotus Edge Valve System