BEUDAMED
    18 results · 29ms · Sources: EU EUDAMED, US FDA

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    PRO QR ADVANCED FORMULA POWDER

    FDA 510(k)
    FDA Unclassified ·Unknown

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074185637·REDUCER 8080210 REDUCED PROFILE T-BOLT

    ITOTAL IDENTITY EXTENSION WRENCH HANDLE

    FDA UDI
    Conformis, Inc.·00810933030483·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450053126·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450179338·

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023932·PADDLE SPREADER, 10MM

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102100·Shaver, Open 10mm

    Havasu

    FDA UDI
    STRYKER CORPORATION·07613327537338·IV Pole

    CONTROL MODULE ALGORITHM ENHANCEMENT FOR THE MODEL S500-ST AND MODEL S400

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

    MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 29, 2026

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 7, 2025

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 9, 2021

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·April 26, 2013

    CALCAR PLANER

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code LXH·April 7, 2011

    MAVIG

    FDA Adverse Event
    Other ·MAVIG. GMBH·Product code KPY·July 15, 2008

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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