494 results · 17ms · Sources: EU EUDAMED, US FDA

Test, Urea Adult And Pediatric (Breath),

FDA Pre-Market Approval
FDA Class 3 ·PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500)

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon Duet® PRO Dual Pack

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System

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

FDA Pre-Market Approval
FDA Class 3 ·Arctic Front Advance®, Arctic Front Advance Pro® Cardiac CryoAblation Catheters

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·CORDIS PRECISE NITINOL & RX NITINOL & PRO RX NITINOL STENT SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·DIVA PLATFORM IMPLANTABLE PULSE GENERATORS AND PRO VIT APPLICATION SOFTWARE VERSION 3.3.2

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·PRO OSTEON IMPLANT 500 POROUS HYDROXYAPATITE BONE GRAFT SUBSTITUTE BLOCKS & GRANULES

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval
FDA Class 3 ·PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·Ophthalmic Viscoelastic Devices, Healon Duet Dual Pack and Healon Duet PRO Dual Pack

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

FDA Pre-Market Approval
FDA Class 3 ·Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve System, Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System

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

FDA Pre-Market Approval
FDA Class 3 ·Artic Front Advance Cardiac Cryoablation Catheter, Artic Front Advance Pro Cardiac Cryoablation Catheter

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·CORDIS PRECISE RX NITINOL STENT SYSTEM & PRECISE PRO RX NITINOL STENT SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve System / Medtronic CoreValve Evolut R System/ Medtronic CoreValve Evolut PRO System

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

FDA Pre-Market Approval
FDA Class 3 ·Arctic Front Advance Cardiac Cryoablation Catheter, Arctic Front Advance Pro Cardiac Cryoablation Catheter

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

FDA Pre-Market Approval
FDA Class 3 ·Arctic Front Advance™ Cardiac Cryoablation Catheter, Arctic Front Advance Pro™ Cardiac Cryoablation Catheter