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, and Impella 5.5 with SmartAssist

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED 3 Defibrillator with Uni-Padz

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·Falope-Ring® Band and Applicator Systems

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS Ambicor Inflatable Penile Prosthesis

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·CORMET HIP RESURFACING SYSTEM

Stent, Urethral, Prostatic, Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·THE SPANNER TEMPORARY PROSTATIC STENT AND ACCESSORIES

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3100/3100A HIGH FREQUENCY OCILLATORY VENT.

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MODEL 3000 CONSTANT FLOW IMPLANTABLE INFUSION PUMP WITH BOLUS SAFETY VALVE

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·UROLUME(R) ENDOPROSTHESIS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

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

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF(R) (GRAFTSKIN)

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA 2.5 SYSTEM

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA CP with Smart Assist

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·ARTEGRAFT COLLAGEN VASCULAR GRAFT

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR ANTI-HBC IGM

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER