230 results · 19ms · Sources: EU EUDAMED, US FDA

Tympanostomy Tube Delivery Product With Drug

FDA Pre-Market Approval
FDA Class 3 ·Tula System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Ellipse DR, Ellipse VR

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

FDA Pre-Market Approval
FDA Class 3 ·Avant, Entrant, Gallant, Neutrino NxT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Avant, Entrant, Gallant, Neutrino NxT

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Protégé GPS and Protégé RX Carotid Stent Systems, and Protégé GPS Peripheral Stent Systems

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SICD Gen 2, SICD MRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SICD Gen 2, SICD MRI

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

FDA Pre-Market Approval
FDA Class 3 ·Gen V CryoConsole RoHS Compliant

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SICD Gen 2, SICD MRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SICD Gen 2, SICD MRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SICD Gen 2, SICD MRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·MODEL 7271 GEM DR, MODEL 7273 GEM II DR, MODEL 7275 GEM III DR ICDS

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·CERVISTA HPV 16/18 TEST

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·CERVISTA HPV HR TEST

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Protege GPS and Protege RX Carotid Stent System; Protege GPS Self-expanding Peripheral Stent System (Iliac)

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·PROTEGE GPS/RX CAROTID STENT SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·SICD Gen 2 and SICD MRI

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Intraocular Lenses with the AutonoMe Delivery System

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Protégé GPS Self Expanding Peripheral Stent System

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·PROTEGE GPS SELF EXPANDING PERIPHERAL STENT SYSTEM