Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ENROUTE Transcarotid Stent System

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix Drug Coated Balloon

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·LVIS and LVIS Jr.

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·Zilver PTX Drug-Eluting Peripheral Stent

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·Patient-Fitted TMJ Reconstruction Prosthesis System

System, Non-Coherent Light, Photodynamic Therapy

FDA classification

FDA Class 3 ·System, Non-Coherent Light, Photodynamic Therapy

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA classification

FDA Class 3 ·Implantable Pulse Generator, Pacemaker (Non-Crt)

Stimulator, Functional Walking Neuromuscular, Non-Invasive

FDA classification

FDA Class 3 ·Stimulator, Functional Walking Neuromuscular, Non-Invasive

Implant, Collagen For Non-Aesthetic Use

FDA classification

FDA Class 3 ·Implant, Collagen For Non-Aesthetic Use

Pacemaker/Icd/Crt Non-Implanted Components

FDA classification

FDA Class 3 ·Pacemaker/Icd/Crt Non-Implanted Components

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA classification

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

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA classification

FDA Class 3 ·Agent, Absorbable Hemostatic, Non-Collagen Based

Ceramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses

FDA classification

FDA Class 3 ·Ceramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA classification

FDA Class 3 ·Temporary Non-Roller Type Right Heart Support Blood Pump

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA classification

FDA Class 3 ·Temporary Non-Roller Type Left Heart Support Blood Pump

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA classification

FDA Class 3 ·Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling

FDA classification

FDA Class 3 ·Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling

Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

FDA classification

FDA Class 3 ·Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

FDA classification

FDA Class 3 ·Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed