167 results · 19ms · Sources: EU EUDAMED, US FDA

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·LIFE PULSE HIGH FREQUENCY JET VENTILATOR

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·LIFE PULSE HIGH FREQUENCY JET VENTILATOR

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·Mobi-C Cervical Disc Prosthesis for use at One or Two Levels

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·LIFE PULSE HIGH FREQUENCY VENTILATOR ENDOTRACHEAL TUBE ADAPTER

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP System, Impella RP with SmartAssist System

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella 2.5 System, Impella CP System, Impella CP with SmartAssist System, Impella 5.0 System, Impella LD System,Impella

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC COREVALVE SYSTEM

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·PROSTATRON

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·PROLIEVE THERMODILITATION SYSTEM

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·UROLOGIX TARGIS SYSTEM FOT THE TREATMENT OF BPH

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·UROLOGIX TARGIS SYSTEM

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·PROSTATRON

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·PROLIEVE THERMODILITATION SYSTEM

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·PROLIEVE THERMODILATATION SYSTEM CATHETER AND HEAT EXCHANGER

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·TMX-2000 BPH THERMOTHERAPY SYSTEM

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·CORETHERM SYSTEM MICROWAVE THERMOTHERAPY

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·UROLOGIX TARGIS SYSTEM