Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LifePulse High Frequency Ventilator

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·WOLVERINE Coronary Cutting Balloon

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·PROMETRA PROGRAMMABLE IMPLANTABLE PUMP

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC ON COBAS E 601

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SPINAL CORD STIMULATION (ITREL SYNERGY, SYNERGY VERSITREL, RESTOREPRIME, RESTORE ADVANCED, PRIME ADVANCED RESTOR ULTRA,

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·REPLY AND ESPIRIT FAMILY OF PACEMAKERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE NXT 2.0 PATIENT MANAGEMENT SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·VOLTA(1CR/2CR/CT/2CT) ICD LEAD, PROTEGO (S/SD/T/TD) ICD LEAD,KAINOX VCS 60 ICD LEADLINOX SMART (S/SD/T/TD/S DX) ICD LEAD

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·PERIMOUNT PERICARDIAL BIOPROSTHESES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 6998 IS-1 LEAD PORT PLUG

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGIFOAM ABSORBABLE GELATIN SPONGE

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Infinity Deep Brain Stimulation (DBS) System

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Certitude Delivery System: 9600SDS20, 9600SDS23, 9600SDS26, 9600SDS29, 9630TA20, 9630TA23, 9630TA26, 9630TA29 Ed