BEUDAMED
    9 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I collagen (nominally 99%) derived from tendon and small quantities of glycosaminoglycans (GAGs: chondroitin sulfate and sodium hyaluronate). The device functions as a resorbable scaffold that is replaced by the patient s own tissue.The CMI device is designed to function as an absorbable template to facilitate host meniscus tissue regeneration in patients who have an irreparable meniscus tear or loss of meniscus tissue. The CMI meniscus tissue through the implant s absorption and replacement by patient s native tissue.

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·March 21, 2018

    Ami HTX.

    FDA Enforcement
    Class II ·Ongoing·Spectral Instruments Inc·June 25, 2025

    HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144

    FDA Enforcement
    Class II ·Ongoing·Mizuho OSI·August 31, 2022

    Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.

    FDA Enforcement
    Class II ·Ongoing·Mizuho OSI·March 31, 2021

    Lago X

    FDA Enforcement
    Class II ·Ongoing·Spectral Instruments Inc·June 25, 2025

    Am I Pregnant? One Step HCG Pregnancy Test REF 100-17

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740

    FDA Enforcement
    Class II ·Ongoing·Ortho-Clinical Diagnostics, Inc.·December 4, 2024

    UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term duration, especially in ophthalmology Art.no. / REF no.: 15000004 Art.no. / REF no.: 15000006

    FDA Enforcement
    Class II ·Ongoing·UFSK - International OSYS Gmbh·July 26, 2023

    Recreo Hair Growth Laser Comb

    FDA Enforcement
    Class II ·Ongoing·OMM Imports, Inc. dba Zero Gravity·March 22, 2023