1,516 results · 21ms · Sources: EU EUDAMED, US FDA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·SMARTABLATE SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Guardian Connect System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·LDR Spine Mobi-C® Cervical Disc Prosthesis

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval
FDA Class 3 ·THE HEART LASER-TM CO2 TMR SYSTEM (THE HEART LASER)

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LADARVISION EXCIMER LASER SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·LDR Spine Mobi-C Cervical Disc Prosthesis

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Cerene® Cryotherapy Device

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK AV, PRIZM, VITALITY, VITALITY AVT IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

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

FDA Pre-Market Approval
FDA Class 3 ·CONTAK CD AND RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK PRIZM 2 VR/DR MODELS 1860/1861, VENTAK PRIZM VR/DR MODELS 1850/1851/1855/

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·SELOX SR STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEAD MODELS SR45, SR53, SR60 SR 53,SELOX SR 60

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK PRIZM 2 VR/DR MODELS 1860/1861; VENTAK PRIZM VR/DR MODELS 1850/1851/1855/1856; VENTAK PRIZM VR/DR HE MODELS 1852

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

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

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·VITAGEL SURGICAL HEMOSTAT

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SYNCHROMED INFUSION SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Restore, Itrel, and Synergy Spinal Cord Stimulation System and Pisces, Specify and Vectris Spinal Cord Stimulation Lead