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

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    Polaris Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777471·LUMBAMED PLUS FLEX PAD WM SILVER V

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777525·LUMBAMED PLUS FLEX PAD M SILVER V

    Sportex

    FDA UDI
    Diversified Products, Inc.·00842894170601·

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319721995·Rubin Dorsal Osteotome 7" (17.5cm), 16mm wide

    DRYSTAR 4500 PRINTER, MODEL 4500

    FDA 510(k)
    FDA Class 2 ·Radiology

    ORTHO EASY PIN

    FDA 510(k)
    FDA Class 2 ·Dental

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·August 29, 2019

    UNFOLDER PLATINUM 1 SERIES

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON VISION CARE, INC. - US·Product code KYB·July 11, 2023

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·October 22, 2008

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DTQ·August 8, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·July 8, 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