BEUDAMED
    22 results · 20ms · Sources: EU EUDAMED, US FDA

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    Stream 17

    Device
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·On the market·7 countries

    Stream XL

    Device
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·On the market·7 countries

    Stream

    Device
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·On the market·8 countries

    BioProtect Balloon Implant System

    Device
    EU MDR · Eu Md Class 3 ·BioProtect·On the market·2 countries

    Cascade L Agile

    Device
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·On the market·7 countries

    Cascade L

    Device
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·On the market·7 countries

    Cascade 17

    Device
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·On the market·8 countries

    Cascade M Agile

    Device
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·On the market·7 countries

    Cascade M

    Device
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·On the market·8 countries

    Bioprotect Balloon Implant System

    Basic UDI-DI
    EU MDR · Eu Md Class 3 ·BioProtect·1 device

    Stream

    Basic UDI-DI
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·3 devices

    Cascade M

    Basic UDI-DI
    EU MDR · Eu Md Class 3 ·Perflow Medical Ltd.·5 devices

    Perflow Medical Ltd.

    Manufacturer
    🇮🇱 Israel·5 Importers·DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, and DQS Medizinprodukte GmbH

    Perflow Medical Ltd.

    Manufacturer
    🇮🇱 Israel·11 Basic UDI-DIs·21 Devices·5 Importers·DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, and DQS Medizinprodukte GmbH

    BioProtect

    Manufacturer
    🇮🇱 Israel·2 Basic UDI-DIs·2 Devices·1 Importer·DEKRA Certification B.V. and DEKRA Certification B.V.

    TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and urologic endoscopic procedures, to create and maintain a port of entry and to facilitate the delivery of absorbable sutures and anchors through soft tissues of the body during endoscopic / laparoscopic surgery. The trocar may be used with or without visualization for primary and secondary insertions. It is comprised of a single patient use, bladeless Obturator designed to allow penetration and positioning at the required site within the abdomen, and several single use Cannulas, which serve as working channels for the procedure. The Cannulas are pre-loaded with two synthetic absorbable sutures, each attached to a synthetic absorbable anchor. The deployment of the anchors and sutures is achieved by utilizing a mechanism within the Obturator. The Cannula is 115 mm long and is compatible for use with laparoscopic devices of 5 - 12 mm outer diameter.

    FDA Enforcement
    Class II ·Terminated·Gordian Surgical·November 11, 2020

    1000169818

    Certificate
    MDR QMS·Perflow Medical Ltd.·DQS Medizinprodukte GmbH

    170783435

    Certificate
    MDR Technical Documentation·Perflow Medical Ltd.·DQS Medizinprodukte GmbH

    170781760

    Certificate
    MDR Technical Documentation·Perflow Medical Ltd.·DQS Medizinprodukte GmbH

    542544 MDR2017P

    Certificate
    MDR Technical Documentation·Perflow Medical Ltd.·DQS Medizinprodukte GmbH·1 Basic UDI-DI