Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

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

FDA Pre-Market Approval

FDA Class 3 ·myChoice CDx

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (F1CDx)

Stent Graft, Infrapopliteal, Venous Arterialization

FDA Pre-Market Approval

FDA Class 3 ·LimFlow System

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·HYALGAN(R)

Barrier, Adhesion, Cardiovascular

FDA Pre-Market Approval

FDA Class 3 ·REPEL-CV BIORESORBABLE ADHESION BARRIER

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·SOLESTA INJECTABLE GEL

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM (PEDIATRIC)

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·VIVA QUAD XT CRT-D,VIVA QUAD S CRT-D,BRAVA QUAD CRT-D,VIVA QUAD C CRT-D,VIVA/BRAVA/EVERA SOFTWARE APPLICATION

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE 2000 SYSTEM

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·BAROSTIM NEO® System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CALRION CII BIONIC EAR SYSTEM (ADULT)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK MONITOR,CARDIOSIGHT READER,CARELINK EXPRESS,DEVICE DATA MANAGEMENT APPLICATION(DDMA)

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASOSEAL 4-5 FRENCH SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·SURESTAT ARTERIAL CLOSURE SYSTEM

Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

FDA Pre-Market Approval

FDA Class 3 ·Optune Lua