10,000 results · 30ms · Sources: EU EUDAMED, US FDA

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE FIX/NOVUS LEAD DRUG COMBINATION/SURE FIX/VITATRON PIROUET+/VITATRON CRYSTALINE LEAD DRUG COMBINATION

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CAPSURE FIX NOVUS/SUREFIX LEADS/CAPSURE FIX/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET+/VITATRON PIROUET S+

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AMO SILICONE MONOFOCAL AND MULTIFOCAL INTRAOCULAR LENS

Ventilator, High Frequency

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

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·AMO SILICONE MONOFOCAL AND MULTIFOCAL INTRAOCULAR LENS

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval
FDA Class 3 ·CapSure Fix Novus Lead (4076, 5076)

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·MODEL 5076 CAPSURE FIX NOVUS ELECTRODE

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

FDA Pre-Market Approval
FDA Class 3 ·Maestro™ Ablation Connection Box, IntellaNav™ OI

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli

Ventilator, High Frequency

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

Prosthesis, Finger, Constrained, Metal/Polymer

FDA Pre-Market Approval
FDA Class 3 ·TOTAL TRAPEZIO METACARPAL PROSTHESIS

Prosthesis, Finger, Constrained, Metal/Polymer

FDA Pre-Market Approval
FDA Class 3 ·TOTAL TRAPEZIO METACARPAL PROSTHESIS

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System and WATCHMAN FLX Pro Left Atrial Appendage

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·LT-CAGE LUMBAR TAPERED/INTER FIX THREADED/INTER FIX RP THREADED/PERIMETER INTERBODY FUSION DEVICE, CLYDESDALE SPINAL SYS

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure D

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl