9,293 results · 23ms · Sources: EU EUDAMED, US FDA

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Air Optix Aqua for Astigmatism / Aqua Multifocal / plus Hydraglyde / plus Hydraglyde Multifocal / plus Hydraglyde for As

Device, Testicular Hypothermia

FDA Pre-Market Approval
FDA Class 3 ·REPRO-MED - THD

Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval
FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYSTEM

Device, Testicular Hypothermia

FDA Pre-Market Approval
FDA Class 3 ·REPRO-MED - THD ADDRESS CHANGE / MANU. FACILITY

Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval
FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYSTEM

Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval
FDA Class 3 ·OPTICAL BIOPSY(TM) SYSTEM

Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval
FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYTEM

Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval
FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYSTEM

Device, Testicular Hypothermia

FDA Pre-Market Approval
FDA Class 3 ·REPRO-MED - THD

Device, Testicular Hypothermia

FDA Pre-Market Approval
FDA Class 3 ·REPRO-MED - THD

Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval
FDA Class 3 ·WAVSTAT (TM) OPTICAL BIOPSY SYSTEM

Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval
FDA Class 3 ·OPTICAL BIOPSY(TM) SYSTEM

Device, Testicular Hypothermia

FDA Pre-Market Approval
FDA Class 3 ·REPRO-MED - THD

Device, Testicular Hypothermia

FDA Pre-Market Approval
FDA Class 3 ·REPRO-MED - THD

Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval
FDA Class 3 ·WAVSTAT OPTICAL BIOPSY SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve™ Evolut™ Pro Transcatheter Aortic Valve, Medtronic Evolut™ Pro+ Transcatheter Aortic Valve, Medtroni

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve Evolut R Transcatheter Aortic Valve (TAV)

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve Evolut PRO TAV, and Avalus Bioprosthesis

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·THE BELOS, TACHOS ATX, AND LEXOS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR FAMILIES AND CARDIAC AIRBAG

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·WOLVERINE™ Coronary Cutting Balloon®