185 results · 20ms · Sources: EU EUDAMED, US FDA

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MAESTRO System Software 8.0

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·EC-5000 EXCIMER LASER SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·RELIANCE ACTIVE FIX & RELIANCE PASSIVE FIX STERIOD ELUTING ENDOCARDIAL DEFIBRILLATION LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE FIX MRI LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE FIX NOVUS/VITATRON

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE FIX MRI LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CapSure Fix MRI Lead

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SOFLENS (POLYMACON) CONTACT LENSES

Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

FDA Pre-Market Approval
FDA Class 3 ·RESQCPR SYSTEM

Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

FDA Pre-Market Approval
FDA Class 3 ·RESQCPR SYSTEM

Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

FDA Pre-Market Approval
FDA Class 3 ·ResQCPR System

Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

FDA Pre-Market Approval
FDA Class 3 ·ResQCPR System

Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

FDA Pre-Market Approval
FDA Class 3 ·ResQCPR™ System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·REVO MRI, CAPSURE FIX LEAD

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION DEVICE FITTING SOFTWARE (SCLIN)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE FIX MRI LEAD, 5086MRI

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·ISOMED FIXED RATE INFUSION PUMP

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSUREFIX & CRYSTALLINE ACT FIX

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·POLARx FIT Cryoablation Balloon Catheters

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HARMONY HIRESOLUTION BIONIC EAR SYSTEM