Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·ELECTROMECHANICAL ENHANCEMENT TO DRIVER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·OG(R) CARDIAC PACING SYSTEM

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WCD 3000

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·IPRO2 RECORDER, IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT

Transcatheter Septal Occluder (Atrial)

FDA Pre-Market Approval

FDA Class 3 ·Occlutech ASD Occluder, Occlutech Pistol Pusher (OPP), Occlutech ASD Occluder Procedure Pack

Transcatheter Septal Occluder (Atrial)

FDA Pre-Market Approval

FDA Class 3 ·Occlutech® ASD Occluder and Occlutech® Pistol Pusher

Transcatheter Septal Occluder (Atrial)

FDA Pre-Market Approval

FDA Class 3 ·Occlutech® ASD Occluder and Occlutech® Pistol Pusher

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ALGOVITA SPINAL CORD STIMULATION SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Prospera SCS System, Resilience Surgical Lead, Embrace One

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Synergy Ablation System

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX Reflux Management System

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX REGLUX MANAGEMENT SYSTEM

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Synergy Ablation System

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·EPi-Sense®, EPi-Sense ST™ Guided Coagulation System

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval

FDA Class 3 ·BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)