95 results · 29ms · Sources: EU EUDAMED, US FDA

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

FDA Pre-Market Approval
FDA Class 3 ·PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILES OF CRT-D DEVICES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·KAMRA INLAY

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·DURATA LEADS

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·ALLEGRO TOPOLYZER VARIO

Electrosurgical, Radio Frequency, Refractive Correction

FDA Pre-Market Approval
FDA Class 3 ·VIEWPOINT(TM) CK SYSTEM

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval
FDA Class 3 ·DAKOCYTOMATION EGFR PHARMDX

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval
FDA Class 3 ·EGFR pharmDx

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval
FDA Class 3 ·EGFR pharmDx

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval
FDA Class 3 ·EGFR pharmDx

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval
FDA Class 3 ·EGFR pharmDx

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval
FDA Class 3 ·DAKOCYTOMATION EGFR PHARMDX KIT

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval
FDA Class 3 ·DAKO EGFR PHARMDX KIT

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval
FDA Class 3 ·EGFR pharmDx

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC SPRINT FIDELIS LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval
FDA Class 3 ·PROTEGO DF-1 LEAD FAMILY

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

FDA Pre-Market Approval
FDA Class 3 ·ICD INOGEN CRT-D DF4/IS1, ICD INOGEN CRT-D DF/IS1/IS1, ICD INOGEN CRT-D DF1/IS1/IS4, ICD INOGEN CRT-D DF4/IS1/IS4, ICD D

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM