45 results · 16ms · Sources: EU EUDAMED, US FDA

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval
FDA Class 3 ·OrganOx metra® System

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·Cologuard®

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense Continuous Glucose Monitoring System

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (r

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 IVL Catheter

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense Continuous Glucose Monitoring System

Embolization Agent, Vascular

FDA Pre-Market Approval
FDA Class 3 ·LAVA® Liquid Embolic System (LAVA LES)

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense® E3 Continuous Glucose Monitoring System

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave Intravascular System with the C2/C2+ Coronary IVL Catheter

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense E3 Continuous Glucose Monitoring System

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense® E3 Continuous Glucose Monitoring (CGM) System

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) Generator, Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense E3 Continuous Glucose Monitoring System

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval
FDA Class 3 ·Shockwave Medical, Inc. IVL Generator and Connector Cable Kit, Shockwave C2 Coronary IVL Catheter