Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·LOTUS Edge Valve System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·CoreValve™ EnVeo™ R Delivery Catheter System, CoreValve™ EnVeo™ PRO Delivery Catheter System, Evolut™ PRO+ Delivery Cath

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN XT Transcatheter Heart Valve

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Commander Delivery System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC COREVALVE SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Sapien XT Transcatheter Heart Valve

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN XT TRANSCATHETER HEART VALVE

Anmar sp. z o.o.

Importer

🇵🇱 Poland·1 Manufacturer

PDT, Inc.

System producer

🇺🇸 United States

Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

FDA classification

FDA Class 2 ·Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control

Factor Xiii A, S, Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Factor Xiii A, S, Antigen, Antiserum, Control

AF531

FDA UDI

Respironics, Inc.·00606959008120·AF531 Mask with Entrainment Elbow, Leak 1, Circ...

AF541

FDA UDI

Respironics, Inc.·00606959046573·AF541 Under the Nose Mask with Entrainment Elbo...

AF531

FDA UDI

Respironics, Inc.·00606959008137·AF531 Mask with Entrainment Elbow, Leak 1, Circ...

AF531

FDA UDI

Respironics, Inc.·00606959008816·AF531 Mask with Entrainment Elbow, Leak 2, with...

Performax

FDA UDI

Respironics, Inc.·00606959013698·Performax Mask with Entrainment Elbow, Leak 2, ...

AF531

FDA UDI

Respironics, Inc.·00606959004566·AF531 Mask with Entrainment Elbow, LEAK 1, with...

AF531

FDA UDI

Respironics, Inc.·00606959007482·AF531 Mask with Entrainment Elbow, Leak 1, Nebu...

AF531

FDA UDI

Respironics, Inc.·00606959008809·AF531 Mask with Entrainment Elbow, Leak 2, 4 Po...