10,000 results · 34ms · Sources: EU EUDAMED, US FDA

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·PERFLUORON

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G Pump

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SynchroMed Infusion System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·ENLITE SENSOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SPRINT/SPRINT QUATTRO/SPRINT QUATTRO SECURE LEAD/TRANSVENE SVC/DF-1 LEADS/SPRINT QUATTRO SINGLE COIL/END CAP ACCESSORY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·DEFIBRILLATION SUPPORT DEVICE/OVAL PATCH LEAD/LEAD END PIN CAP/ACE ACCESSORY/UPSIZING SLEEVE FOR HV LEAD DF-1

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·ACCESSORY (UPSIZING SLEEVE)/UNIPOLAR/GEM/PCD TACHY CONTROL SYSTEM/JEWEL/LEAD END PIN CAP/MICRO JEWEL/II/TRANSVENE DEFIBR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·LV Lead Quadpole Connector IS4, Accessory Kit Lead Cap, Accessory Stylet TAPER FIX SOFT 64CM, 70CM, and 100CM, Accessory

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 630G system

Glue, Surgical, Arteries

FDA Pre-Market Approval
FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·GELSYN-3

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G system, MiniMed 770G system and MiniMed 780G system

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

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

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM G4 PLATINUM CONTINOUS GLUCOSE MONITORING SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM