BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.

    FDA Recall
    Open, Classified ·Breas Medical, Inc.·Product code NOU·October 13, 2023

    BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902 BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite" VALVES, Catalog # 20062E; BD SECONDARY SET VENTED NONVENTED 20 DROP W/ 2 HANGERS, Catalog # 70000N-07; BD MaxGuardTM tri-fuse extension set, Catalog # ME1224; BD 20-IN EXTENSION SET W/ 0.2 MICRON FILTER ONE SmartSiteTM VALVE AND TexiumTM, Catalog # 20350ET; BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TexiumTM AND HANGER LOW SORBING, Catalog # 70001B-07T.

    FDA Recall
    Open, Classified ·Becton Dickinson & Company·Product code FPA·October 11, 2023

    Tenaculum, Plastic

    FDA Recall
    Open, Classified ·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021

    IUD Insertion Pack

    FDA Recall
    Open, Classified ·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021

    Foundation Kit

    FDA Recall
    Open, Classified ·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021

    7.5 cm Large Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium

    FDA Recall
    Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

    Standard IUD Insertion Kit

    FDA Recall
    Open, Classified ·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021

    6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel

    FDA Recall
    Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

    6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium

    FDA Recall
    Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

    Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium

    FDA Recall
    Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

    6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium

    FDA Recall
    Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

    Pediatric Craniotome Ref:CRANI-P-G1

    FDA Recall
    Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

    The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants.

    FDA Recall
    Open, Classified ·Powers Medical Devices, LLC·Product code HCC·October 1, 2015

    IUD Insertion Kit

    FDA Recall
    Open, Classified ·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021

    Endometrial Biopsy Kit

    FDA Recall
    Open, Classified ·Stradis Medical, LLC dba Stradis Healthcare·Product code HDC·September 10, 2021

    7.5 cm Large Craniotome Attachment Use with XMax, microMax, and eMax Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium

    FDA Recall
    Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

    6.5 cm Pediatric Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium

    FDA Recall
    Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

    Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium

    FDA Recall
    Open, Classified ·The Anspach Effort, Inc.·Product code HBC·December 7, 2022

    BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to the status of a patients physiological parameters so that the patient can control voluntarily these physiological parameters.

    FDA Recall
    Open, Classified ·RONAN MEDICAL LLC·Product code HCC·December 11, 2023