BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    UROMAX ULTRA BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Medline Industries, Inc.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10889942133864·BIAS STCKNT 6 KIT

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526159525·PROTECT.EPI ELBOW SUPPORT GRAY IV

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857562363·Lordotic Trial Size 22x50x8 mm, 8°

    AMT G-J TUBE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025

    SPECTRA WAVEWRITER?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 7, 2025

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 24, 2013

    ATTAIN ABILITY PLUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011

    SHILEY DISPOSABLE CANNULA

    FDA Adverse Event
    Death ·COVIDIEN/FORMERLY TYCO HEALTH·Product code BTO·August 20, 2008

    ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZE·February 17, 2014

    ViewForum Review Station Part Numbers: 9896 507 71830, 9896 507 71831, and 9896 507 71832.

    FDA Recall
    Terminated ·Philips Medical Systems Sales & Service Region No. America·Product code LLZ·June 8, 2004

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018