Sensor, Glucose, Invasive, Non-Adjunctive

FDA classification

FDA Class 3 ·Sensor, Glucose, Invasive, Non-Adjunctive

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA classification

FDA Class 3 ·Sensor, Glucose, Implanted, Non-Adjunctive Use

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

FDA Pre-Market Approval

FDA Class 3 ·Guardant360 CDx

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx

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

FDA Pre-Market Approval

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

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·Neuroform Atlas® Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne Liquid CDx

Barrier, Adhesion, Cardiovascular

FDA classification

FDA Class 3 ·Barrier, Adhesion, Cardiovascular

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA classification

FDA Class 3 ·Drug-Eluting Peripheral Transluminal Angioplasty Catheter

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

FDA classification

FDA Class 3 ·Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA classification

FDA Class 3 ·Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·OBALON BALLOON SYSTEM