BEUDAMED
    219 results · 47ms · Sources: EU EUDAMED, US FDA

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    Pathwai, Inc

    FDA registration
    Pathwai, Inc·6 products·🇺🇸 United States

    AISight Dx

    FDA UDI
    PathAI, Inc.·00860006696221·

    MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal, straight non-tapered tip; PK1018-03A; Bard Peripheral Vascular; Manuf: Flow Cardia, Inc., a Subsidiary of C.R. Bard, Inc. 745 North Pastoria Ave., Sunnyvale, CA 94085. The MicroSheath and Usher Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature. MicroSheath¿ is a single lumen catheter that has a 123cm working length and a straight tip shape

    FDA Enforcement
    Class II ·Terminated·Bard Peripheral Vascular Inc·June 19, 2013

    MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Biocardia, Inc.·February 26, 2014

    Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Biocardia, Inc.·April 2, 2014

    JETSTREAM G3

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES INC.·Product code MCW·January 20, 2012

    JETSTREAM G3

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES, INC.·Product code MCW·February 9, 2012

    JETSTREAM G3

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES, INC.·Product code MCW·February 15, 2012

    JETSTREAM G3

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES INC.·Product code MCW·February 16, 2012

    PATHWAY JETSTREAM

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES INC.·Product code MCX·March 11, 2009

    JETSTREAM G2

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES, INC.·Product code MCX·March 19, 2009

    PATHWAY JETSTREAM

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES INC.·Product code MCX·March 23, 2009

    JETSTREAM

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES, INC.·Product code MCW·March 5, 2010

    JETSTREAM G3

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES INC.·Product code MCW·March 11, 2010

    JETSTREAM G3

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES INC.·Product code MCW·March 11, 2010

    JETSTREAM G3

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES, INC.·Product code MCW·March 25, 2010

    JETSTREAM G3 L

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES INC.·Product code MCW·March 26, 2010

    JETSTREAM G3

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES INC.·Product code MCW·March 24, 2010

    JETSTREAM G3

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES, INC.·Product code MCW·March 25, 2010

    JETSTREAM G3

    FDA Adverse Event
    Injury ·PATHWAY MEDICAL TECHNOLOGIES, INC.·Product code MCW·January 13, 2010