4,131 results · 44ms · Sources: EU EUDAMED, US FDA

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Accolade Non-MRI Pacemakers: ALTRUA 2, ESSENTIO, PROPONENT and ACCOLADE

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

FDA Pre-Market Approval
FDA Class 3 ·NG3 Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Devices: AUTOGEN, DYNAGEN, INOGEN and ORIGEN; NG4 CRT-D Devi

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Accolade MRI Pacemakers: ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI

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

FDA Pre-Market Approval
FDA Class 3 ·Accolade Cardiac Resynchronization Therapy-Pacemaker (CRT-P) Devices: VALITUDE, VALITUDE, and VISIONIST

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·NG3 Implantable Cardiac Defibrillators (ICDs): AUTOGEN, DYNAGEN, INOGEN and ORIGEN; NG4 ICDs: MOMENTUM, VIGILANT, PERCIV

Implant, Cochlear

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

Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·MIC PANELS

Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·MIC PANELS

Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·MIC PANELS

Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·MIC PANELS

Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·MIC PANELS

Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·MIC PANELS

Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·MIC PANELS

Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·MIC PANELS

Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·MIC PANELS

Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·MIC PANELS

Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·MIC PANELS

Panels, Test, Susceptibility, Antimicrobial

FDA Pre-Market Approval
FDA Class 2 ·MIC PANELS

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WaveLight EX500 Laser System

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WaveLight EX500 Laser System