BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    ARM SLING

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ACUMED

    FDA UDI
    Acumed LLC·10806378050442·Polarus® 3 Proximal Targeting Guide, L

    SURE-SNAP

    FDA UDI
    Gc Orthodontics America Inc.·E53580162600001·SURE-SNAP 1. MOLAR UPR RGT SZ 26

    FLOWPICC CONSOLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LENSX LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CARDIOSAVE HYBRID, TYPE B PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·December 24, 2025

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·May 9, 2014

    JOSTENT GRAFTMASTER

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MAF·October 23, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 25, 2007

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021