BEUDAMED
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    Corvia Medical, Inc.

    Manufacturer
    🇺🇸 United States·1 Basic UDI-DI·1 Device·1 Importer·BSI Group The Netherlands B.V.

    CORVIA MEDICAL, INC.

    FDA registration
    CORVIA MEDICAL, INC.·1 product·🇺🇸 United States

    IASD System II

    Device
    EU MDD · Eu Md Class 3 ·Corvia Medical, Inc.·On the market·11 countries

    IASD System II

    Basic UDI-DI
    EU MDD · Eu Md Class 3 ·Corvia Medical, Inc.·1 device

    CE571156

    Certificate
    MDD Annex II Section 4·Corvia Medical, Inc.·BSI Group The Netherlands B.V.·1 Basic UDI-DI

    Corvia Medical GmbH

    Importer
    🇩🇪 Germany·1 Manufacturer

    ICON (LR) Limited

    Authorized representative
    🇮🇪 Ireland·37 Manufacturers·384 Devices

    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-220, UPN Product No. M001452200, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc., Vaxcel(TM) Port Titanium Mini-Port with 8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-310, UPN Product No. M001453100, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-364, UPN Product No. M001453640, STERILE, Rx Only, For single use only --- Common Name: Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 6F Polyurethane Catheter (1.1 mm/1.9 mm), REF Catalog No. 45-213, UPN Product No. M001452130, STERILE, Rx ONLY, For Single Use Only --- Implantable Vascular Access System with PASV(TM) Valve Technology - (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-362, UPN Product No. M001453620, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc. Vaxcel(TM) Port Titanium Standard Port with 8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-320, UPN # - M001453200, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc. Vaxcel(TM) Port titanium Mini-Port with 7F Polyurethane Catheter (1.3 mm/2.2 mm), REF Catalog No. 45-305, UPN Product No. M001453050, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc., Vaxcel(TM) Port Plastic Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm), REF Catalog No. 45-360, UPN Product No. M001453600, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Plastic Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-366, UPN Product No. M0 01453660, Sterile, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc. Vaxcel(TM) Port titanium Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm), REF Catalog No. 45-315, UPN Product No. M001453150, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port With PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-215, UPN Product No. M001452150, STERILE, Rx ONLY, For Single Use Only --- Implantable Vascular Access System with PASV(TM) Valve Technology (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM), Plastic Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-368, UPN Product No. M001453680, STERILE, Rx ONLY, For Single Use Only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010

    Navilyst Medical, Inc. Vaxcel(TM) Port Titanium Mini-Port with 6F Polyurethane Catheter (1.1 mm/1.9 mm), REF Catalog No. 45-303, UPN Product No. M001453030, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.

    FDA Recall
    Terminated ·Navilyst Medical, Inc·Product code LJT·May 13, 2010