BEUDAMED
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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

    Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide, catalog #5050-00162, and as a component within a Qiagen PC, available as catalog # 5050-11140A. The software calculates and interprets assay results generated by the Digene Microplate Luminometer according to assay validation parameters. The software is used in conjunction with the following QIAGEN products: digene HC2 High-Risk HPV DNA Test [5199-1220 (one-plate); 5199-00016 (four-plate)] digene HC2 HPV DNA Test (5198-1220) digene HC2 CT/GC DNA Test (5130-1220) digene HC2 CT-ID DNA Test (5135-1220) digene HC2 GC-ID DNA Test (5140-1220) digene HC2 CT-GC Dual-ID DNA Test (5145-1220)

    FDA Recall
    Terminated ·QIAGEN Gaithersburg, Inc.·Product code JJQ·January 12, 2011

    6 cm Catheter Reservoir with 10 cm extension

    FDA Recall
    Terminated ·Vygon Neuro·Product code HCA·March 24, 2005

    Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience Kit #31176. The kit contains: one Hermetic Large Style Ventricular Catheter Set, one Ventricular Drainage System, one INS-HITH Cranial Access Kit, one Sodium Chloride 10 ml, and one Suture 2-0 silk.

    FDA Recall
    Terminated ·Integra Life Sciences Corp.·Product code HCA·March 19, 2003

    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

    Codman Holter Salmon Rickham Reservoir with Ventricular Catheter Catalog Number: 82-1617

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·Product code HCA·March 11, 2004

    7 cm Catheter Reservoir with 10 cm extension

    FDA Recall
    Terminated ·Vygon Neuro·Product code HCA·March 24, 2005

    EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation

    FDA Recall
    Terminated ·EEG Info·Product code HCC·November 15, 2012

    Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.

    FDA Recall
    Terminated ·Ondamed Inc·Product code HCC·July 7, 2017

    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

    10 cm Scopable Catheter Reservoir

    FDA Recall
    Terminated ·Vygon Neuro·Product code HCA·March 24, 2005

    CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HCA·March 17, 2021

    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