BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Radiology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776214081·30 Deg Laparoscope, HD

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180135628·5MM DIA., 45CM, ELMED BARIATRIC LAPAROSCOPE, 30...

    N/A

    FDA UDI
    Smith & Nephew, Inc.·00817470002720·CAPS-LOCK ULTRA 8.2MM X 35MM

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 12, 2019

    n/a

    FDA UDI
    Ortho Development Corporation·00822409068012·Stem Extension Trial Diameter 22x150mm

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517085815·

    Echotip

    FDA UDI
    COOK INCORPORATED·00827002163096·Echotip Disposable Amniocentesis Needle

    ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CASPIAN Spinal System

    FDA UDI
    VB Spine LLC·10888857242609·Manipulator

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

    GALILEO ECHO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·January 5, 2016

    COBAS E411 RACK SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code DHA·November 5, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011

    DUROM ACETABULAR COMPONENT 48/42 CODE H

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·July 9, 2013

    Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324

    FDA Enforcement
    Class II ·Terminated·Cayenne Medical Inc.·August 8, 2018

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 2021

    Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGTCFS-65-1-UNI-CELECT-PT G34505;

    FDA Enforcement
    Class III ·Terminated·Cook Medical Incorporated·April 13, 2022

    ACCOLADE DR SL MRI (Model L311)

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