714 results · 21ms · Sources: EU EUDAMED, US FDA

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation System

Imager, Breast, Electrical Impedance

FDA Pre-Market Approval
FDA Class 3 ·TS2000

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM SEVEN SYSTEMS

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·ALCON LADARVISION 4000 EXCIMER LASER SYSTEM-

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·NIGHT & DAY 30 NIGHT EXTENDED WEAR SOFT CONTACT LENS

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·Axonics Sacral Neuromodulation System

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·GELFOAM (ABSORBABLE GELATIN) STERILE SPONGE

Drug-Eluting Sinus Stent

FDA Pre-Market Approval
FDA Class 3 ·PROPEL MINI SINUS IMPLANT

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·LADAR VISION TREATMENTS

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HARMONY HIRESOLUTION BIONIC EAR SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·LUMOS DR-T AND LUMOS VR-T

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

FDA Pre-Market Approval
FDA Class 3 ·EPIC AND ATLAS+ HF CRT-D SYSTEMS

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval
FDA Class 3 ·LungFit PH

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·PHILOS II DR-T

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·STRATOS LV-T

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITOR