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

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    MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033522998·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033519417·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033519448·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033519431·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033519455·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033519400·

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361013013·PedFuse Remind LES, Quad-H, 7.0mm x 45mm

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033522981·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033519424·

    MODIFICATION TO INSTANT-VIEW METHAMPHETAMINE (METH 1000) URINE TEST (DIP STRIP)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MODIFICATION TO OSTEONICS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEURON MAX 6F 088 LONG SHEATH

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DQY·March 20, 2013

    FREESTYLE LITE

    FDA Adverse Event
    Injury ·Product code NBW·March 10, 2011

    RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code LIT·March 14, 2008

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022