BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    Navigated Pedicle Access Kit

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101094·HELVESTON "BIG BARBIE" RETRACTOR 9MM

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07310K1190120·Tray Insert 4, Cosmo MIS, Arcamed

    9.1MHZ PENCIL SHIELDED

    FDA UDI
    PARKS MEDICAL ELECTRONICS, INC.·00816787021417·

    V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ACCELERATOR A3600

    FDA Adverse Event
    Malfunction ·INPECO SA·Product code JQP·December 20, 2024

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 26, 2013

    HARMONY MANUAL BREAST PUMP

    FDA Adverse Event
    Injury ·MEDELA, INC.·Product code HGX·July 29, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 21, 2014

    PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code LPH·October 15, 2025

    ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories, Inc·March 13, 2019