BEUDAMED
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    FDA UDI
    Huangshan Jinfu Medical Equipment Co.,Ltd.·06975582541200·Electric Traction Table

    UNKNOWN

    FDA 510(k)

    UNKNOWN

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNKNOWN

    FDA 510(k)

    UNKNOWN

    FDA 510(k)

    UNKNOWN

    FDA 510(k)

    UNKNOWN

    FDA 510(k)

    UNKNOWN

    FDA 510(k)

    UNKNOWN

    FDA 510(k)

    UNKNOWN

    FDA 510(k)

    UNKNOWN

    FDA 510(k)

    UNKNOWN

    FDA 510(k)
    FDA Class 1 ·Microbiology

    UNKNOWN

    FDA 510(k)

    2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown

    FDA Recall
    Open, Classified ·Tenderneeds Fertility LLC·Product code MQF·December 23, 2020

    2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown

    FDA Enforcement
    Class II ·Ongoing·Tenderneeds Fertility LLC·August 11, 2021

    Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Recall
    Open, Classified ·CooperSurgical, Inc.·Product code PUB·November 15, 2024

    GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·February 5, 2014

    Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·December 25, 2024

    Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JHS·July 24, 2018

    ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code JHS·July 24, 2018