63 results · 28ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SECURA DR/VR, VIRTUOSO II DR/VR AND MAXIMO II DR/VR

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·CONSULTA CRT-D, CONCERTO II CRT-D AND MAXIMO II CRT-D

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval
FDA Class 3 ·NOVOTTF-100A SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE(BEHIND-THE-EAR)T-MIC

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE(BEHIND-THE-EAR)T-MIC

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADVISA SR MRI

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS) Heart

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System™ (OCS™) Heart

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·OCS Heart System

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS) Heart System

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS) Heart System

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System (OCS) Heart System

Organ Care System (Ocs) Heart System

FDA Pre-Market Approval
FDA Class 3 ·Organ Care System™ (OCS™) Heart

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·Animas Vibe System

Occluder, Internal Vessel, Temporary

FDA Pre-Market Approval
FDA Class 3 ·LEGOO

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·Animas Vibe System

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·Animas, Vibe System

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM