BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    Ballancer Platinum (1222)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120700·Steinmann Pin 3.5x230mm (9/64 x 9")

    ALM RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896026629·ALM RETRACTOR DEEP TIPS

    IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COMPRESSIBLE LIMB SLEEVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CATH-LAB SHEATH INTRO SE T:

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DYB·November 7, 2008

    HYLAMER NEUT 54OD X 28ID

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code JDL·September 1, 2011

    HAND F/355.220

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·July 16, 2013

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021