BEUDAMED
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    MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040091583·FILE - Channels RF File - Size 20.06 21MM

    Flexi-Tip

    FDA UDI
    COOK INCORPORATED·00827002140141·Flexi-Tip Ureteral Catheter (Right)

    12MM TAP Cann Hud-Mod

    FDA UDI
    Osteocentric Technologies, Inc.·00810097801233·12MM TAP Cann Hud-Mod

    VERIDIAN

    FDA UDI
    VERIDIAN HEALTHCARE LLC·00845717000284·Provident Aneroid Sphygmomanometer, Child

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515010444·Basket for Half Size Container 9.7 x 9.7 x 3.2"

    BD SPRING BASED SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Eclipse Mini

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522130762·ECLIPSE MINI ECG SENSOR, DEFIB SAFE

    MOMENTUM CRT-D

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code NIK·July 5, 2023

    VACUETTE TUBE 3 ML K2E K2EDTA 13X75 LAVENDER CAP-BLACK RING, NON-RIDGED

    FDA Adverse Event
    Malfunction ·GREINER BIO-ONE NA INC.·Product code JKA·July 22, 2021

    PORTEX SPINAL ANESTHESIA TRAYS

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code CAZ·March 15, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NIQ·March 27, 2008

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·September 17, 2021

    ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    FDA Adverse Event
    Death ·WILLIAM COOK EUROPE·Product code MIH·August 23, 2023

    BACT/ALERT I NST 100 BTLS - 259785

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX INC.·Product code MDB·March 4, 2024

    BD INTREGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·September 3, 2021

    I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.

    FDA Recall
    Open, Classified ·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026

    I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026