BEUDAMED
    7 results · 29ms · Sources: EU EUDAMED, US FDA

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    This product is manufactured by Sansure Biotech Inc..

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

    Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease.

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·March 17, 2021

    BUTTON REPLACEMENT GASTROSTOMY DEVICE

    FDA Adverse Event
    Malfunction ·INTERVENTIONAL PRODUCT DIV. C.R. BARD, INC.·Product code KNT·September 9, 1994

    BEAR 1000

    FDA Adverse Event
    Malfunction ·BEAR MEDICAL SYSTEMS, INC. VENTILATION PRODUCT DIV.·Product code CBK·December 15, 1998

    BREAST PROSTHESIS

    FDA Adverse Event
    Injury ·MENTOR H/S, INC. ATTN: PRODUCT EVAL. DEPT.·Product code FWM·June 30, 1997

    Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912

    FDA Recall
    Terminated ·Clinician's Choice Dental Products Inc.·Product code ELW·March 18, 2022

    Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution

    FDA Recall
    Open, Classified ·Contamac Solutions, Inc.·Product code MRC·May 15, 2025