10,000 results · 36ms · Sources: EU EUDAMED, US FDA

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Biofinity Sphere and Biofinity XR Sphere, Biofinity Toric and Biofinity XR Toric, Biofinity Multifocal, Biofinity Energy

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·RELIANCE FAMILY OF LEADS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·SCS Neurostimulators Implantable Itrel Family/Restore Family

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·DBS Neurostimulator Implantable/Activia Family

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·Implantable System for Remodulin

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·SNS Bowel Neurostimulator/Implantable InterStim

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SynchroMed Infusion System, Ascenda® IntrathecaI Catheters

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·Drug Delivery Infusion Pump/SynchroMed

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

FDA Pre-Market Approval
FDA Class 3 ·HeartLight® X3 Catheter with Excalibur Balloon™

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·SNS Urinary Neurostimulator/Implantable InterStim

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·prodisc C, prodisc C Vivo, prodisc C Nova, prodisc C SK

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRODISC -L TOTAL DISC REPLACEMENT DEVICE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Biofinity (comfilcon A) soft (hydrophilic) contact lenses for extended wear

Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions

FDA Pre-Market Approval
FDA Class 3 ·GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·methafilcon B Soft (Hydrophilic) Extended Wear Contact Lenses

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·tetrafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·PROLIEVE THERMODILATATION SYSTEM CATHETER AND HEAT EXCHANGER