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

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Eyhance™ Toric II, Model ICU, TECNIS Eyhance™ Toric II with TECNIS Simplicity® Delivery System, TECNIS Synergy™ T

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·MYNX VASCULAR CLOSURE DEVICE

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS COCHLEAR IMPLANT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·FRESHLOOK SPHERICAL, TORIC AND BIFOCAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/

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

FDA Pre-Market Approval
FDA Class 3 ·UROLOGIX TARGIS SYSTEM FOT THE TREATMENT OF BPH

System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

FDA Pre-Market Approval
FDA Class 3 ·ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08)

System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

FDA Pre-Market Approval
FDA Class 3 ·ALERT SYSTEM-COMPANION II

Pulse-Generator, Program Module

FDA Pre-Market Approval
FDA Class 3 ·AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER

Pulse-Generator, Program Module

FDA Pre-Market Approval
FDA Class 3 ·MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER

Pulse-Generator, Program Module

FDA Pre-Market Approval
FDA Class 3 ·MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER

Pulse-Generator, Program Module

FDA Pre-Market Approval
FDA Class 3 ·AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER

Pulse-Generator, Program Module

FDA Pre-Market Approval
FDA Class 3 ·BOSTON SCITNTIFIC SCIMED AORTIC VALVULOPLASTY(TM) CATHETER

Pulse-Generator, Program Module

FDA Pre-Market Approval
FDA Class 3 ·MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER

Pulse-Generator, Program Module

FDA Pre-Market Approval
FDA Class 3 ·MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER

Pulse-Generator, Program Module

FDA Pre-Market Approval
FDA Class 3 ·AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER

Pump, Infusion, Implanted, Programmable

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

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Master Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SynchroMed Infusion Systems

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·SYNCHROMED(TM) INFUSION SYSTEM