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

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE FIREFLY (ADULT)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE FIREFLY (PEDIATRIC)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE(BEHIND-THE-EAR)T-MIC

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE(BEHIND-THE-EAR)T-MIC

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE(BEHIND-THE-EAR)SYSTEM SENSOR (PEDIATRIC)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE (BEHIND-THE-EAR) SYSTEM SENSOR (ADULT)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CII BIONIC CAR SYSTEM, HIRES AURIA PROCESSOR AND ACCESSORIES

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MICRONY FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·AFFINITY/INTERNITY/VICTORY FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS

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

FDA Pre-Market Approval
FDA Class 3 ·EPIC HF/ATLAS+HF FAMILY OF CRT-DS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CADENCE FAMILY OF ICDS

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MICRONY FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·PARAGON/PHOENIX FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·PARAGON/PHOENIX FAMILY OF PACEMAKERS

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NeuroPace RNS System

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NeuroPace RNS System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILY OF ICDS