BEUDAMED
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    ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895

    FDA 510(k)
    FDA Class 2 ·Immunology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040019153·Zirlux 16+ 20x19x15 D4

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023918·PADDLE SPREADER, 8MM

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102080·Shaver, Open 8mm

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967186917·Battalion, LLIF Trial, 6°, 22 mm Wide, 08 mm X ...

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07310K0122000·Assembly, Tab Breaker, Extended Tab

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0112080·Tap, 7.50mm

    DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BIOVER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONTACT DETACH

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 13, 2025

    ILET BIONIC PANCREAS

    FDA Adverse Event
    Injury ·BETA BIONICS INC.·Product code QFG·February 11, 2026

    PROTECTA XT CRT-D

    FDA Adverse Event
    Death ·IPG MFG SWITZERLAND·Product code NIK·June 26, 2013

    LAMITRODE S8

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 12, 2013

    CAPIOX SX OXYGENATOR W/ HARDSHELL RESERVOIR

    FDA Adverse Event
    TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTZ·February 25, 2011

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 16, 2007

    PREMICRON GREEN 4/0(1,5)4X45 HR13 TOM

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·January 29, 2020

    PREMICRON GREEN 2/0 (3) 75CM HR26 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAW·June 28, 2019

    PREMICRON GREEN 2/0 (3) 30CM SKR19(M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·February 3, 2020

    PREMICRON G/W 2/0(3)4X90CM2XHRC20MPF6MLP

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019

    PREMICRON GREEN 2/0 (3) 75CM HR26 (M)

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code GAT·December 30, 2019