BEUDAMED
    16 results · 28ms · Sources: EU EUDAMED, US FDA

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    XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3

    FDA 510(k)
    FDA Class 2 ·Radiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517629661·CoRoent Ant TLIF Ti, 12x10x34mm 12°

    ambiT® "PreSet" Ambulatory Infusion Pump

    FDA UDI
    Avanos Medical, Inc.·00193494000837·ambIT* Pain Control Kit - Basic w/Filterless Ma...

    HHM

    FDA UDI
    Sbo Hearing A/S·05714464006533·F40 FW 1.0.0

    ambIT

    FDA UDI
    SUMMIT MEDICAL PRODUCTS, INC.·00857595005244·Pain Control System - Basic with Filterless Mal...

    EMG RECORDING ELECTRODE ASSEMBLY

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    UNIFIL FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    DURALOC APEX HOLE ELIMINATOR

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDL·November 3, 2008

    ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·August 23, 2011

    FORTIFY ASSURA DR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013

    Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342 Made in India. The product is a Class I, IVD dye and chemical stain for use in Hematology.

    FDA Recall
    Terminated ·EMD Chemicals Inc.·Product code KQC·April 4, 2011

    BD MICROLANCE HYPODERMIC NEEDLE 21G X 1.5" GREEN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·January 6, 2023

    GALILEO® LAG SCREW INSERTER

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HSB·October 20, 2025

    Histochemical PAS (Periodic Acid Schiff) Reaction Set' Class I, IVD; Set of 4 bottles including Schiff Reagent 225 mL, Light Green SF Yellowish Stain 225 mL, Sodium Carbonate Solution 225 mL and Periodic Acid Solution 225 mL' EMD Chemicals, Inc. 480 S. Democrat Road, Gibbstown, NJ 08027 Each kit provides reagents sufficient for a maximum of 100 tests.

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code HZT·June 2, 2008

    K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL, and 1 vial reagent 2, Antibody Reagent 50 mL. The product is packaged in a kit box along with with the package insert. The package insert is labeled in part: "K-ASSAY Alpha-1 Microglobulin...Cat. No. KAI-056...For the Quantitative Determination of human Alpha-1 Microglobulin in urine, serum, and plasma...KAMIYA BIOMEDICAL COMPANY...12779 Gateway Drive...Seattle, WA 98168 USA...".

    FDA Recall
    Terminated ·Kamiya Biomedical Company, LLC·Product code MGA·September 17, 2008

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025