46 results · 18ms · Sources: EU EUDAMED, US FDA

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·PERFLUORON

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·CCS MODEL 325 PACEMAKER SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·CCS MODEL 325 PACEMAKER SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CCT.2 CRYOABLATION CONSOLE SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·CCS MODEL 300 PACEMAKER MAESTRO

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·CCT.2 CRYOABLATION CONSOLE SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·CCS MODEL 333 PACEMAKER SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER (EPTC) EXT CBL, SAFIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, EXT CBL, S

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval
FDA Class 3 ·T-SCAN 2000

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval
FDA Class 3 ·TS2000

Kit, Test, In Vitro Periodontal

FDA Pre-Market Approval
FDA Class 3 ·PERIOCHECK TM ENZYME ACTIVITY TEST KIT

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval
FDA Class 3 ·TRANSCAN T-SCAN 2000

Kit, Test, In Vitro Periodontal

FDA Pre-Market Approval
FDA Class 3 ·PERIOCHECK TM ENZYME ACTIVITY TEST KIT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimula

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·CCS MODEL 333 PACEMAKER INTRO. 3 NEW MODELS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·7F Freezor Cardiac CryoablationCatheter and CCT.2 Cryoconsole System