BEUDAMED
    14 results · 13ms · Sources: EU EUDAMED, US FDA

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    Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3) KCFW-10.0-35-45-RB-HFANL0-HC; 4) KCFW-10.0-35-45-RB-HFANL1-HC; 5) KCFW-12.0-35-45-RB-HFANL0-HC; 6) KCFW-12.0-35-45-RB-HFANL1-HC; 7) KCFW-9.0-35-38.5-RB-RTPS-100; 8) KCFW-10.0-35-RB-RTPS-100; 9) KCFW-9.0-38-55-RB-RAABE; 10) KCFW-9.0-38-70-RB-RAABE; 11) KCFW-9.0-38-80-RB; 12) KCFW-10.0-38-30-RB; 13) KCFW-10.0-38-40-RB; 14) KCFW-10.0-38-80-RB; 15) KCFW-10.0-38-RB; 16) KCFW-12.0-38-40-RB; 17) KCFW-12.0-38-80-RB; Flexor Introducers and Guiding Sheaths are designed to perform as a guiding sheath and/or introducer sheath. Flexor Introducers and Guiding Sheaths incorporate a Flexor shaft with a hemostasis valve and are provided with one or more dilators. These devices are available in various sizes, lengths and configurations. Configurations include differences in shaft construction, such as varying shaft stiffness and distal tip material and shape, dilator material, hydrophilic coating and/or distal radiopaque markers.

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code DYB·November 26, 2025

    Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile

    FDA Recall
    Open, Classified ·Folsom Metal Products, Inc.·Product code GCZ·August 21, 2025

    Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 10 single packs , Rx Only, Sterile

    FDA Recall
    Open, Classified ·Folsom Metal Products, Inc.·Product code GCZ·August 21, 2025

    Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile

    FDA Recall
    Open, Classified ·Folsom Metal Products, Inc.·Product code GCZ·August 21, 2025

    Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile

    FDA Recall
    Open, Classified ·Folsom Metal Products, Inc.·Product code GCZ·August 21, 2025

    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

    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

    Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile

    FDA Recall
    Open, Classified ·Folsom Metal Products, Inc.·Product code GCZ·August 21, 2025

    Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile

    FDA Recall
    Open, Classified ·Folsom Metal Products, Inc.·Product code GCZ·August 21, 2025

    Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023070S

    FDA Recall
    Open, Classified ·Sarnova HC, Llc·Product code LNZ·February 12, 2024

    Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.

    FDA Recall
    Open, Classified ·Sarnova HC, Llc·Product code CAE·November 6, 2023

    Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.

    FDA Recall
    Open, Classified ·Sarnova HC, Llc·Product code CAE·November 6, 2023

    Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to establish an airway in an emergency. Item Number: 023060S

    FDA Recall
    Open, Classified ·Sarnova HC, Llc·Product code LNZ·February 12, 2024

    Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts

    FDA Recall
    Open, Classified ·Human Care Hc Sweden Ab Arstaangsvagen 21 B Stockholm Sweden·Product code FSA·February 23, 2024