177 results · 24ms · Sources: EU EUDAMED, US FDA

System, Imaging, Fluorescence

FDA Pre-Market Approval
FDA Class 3 ·KARL STORZ AUTOFLURESCENCE SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·PreVue Pre-loaded System, IPURE Pre-loaded System

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·ANGIOSCULPT PTCA SCORING BALLOON CATHETER,RAPID EXCHANGE (RX0

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NeuroPace RNS System

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

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

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

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

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

FDA Pre-Market Approval
FDA Class 3 ·THERMATRX TMX-3000 OFFICE THERMOTHERAPY SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·PROSTATRON