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

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    STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GC Initial™

    FDA UDI
    Gc America Inc.·D0470128291·Initial LiSi Press Ingot MT-B3 (3gx5)

    EYE SENTIAL

    FDA UDI
    FGX INTERNATIONAL INC.·00193033444801·

    POWDER FREE ELASTIC VINYL EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DJ ORTHOPEDICS FEMORAL ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD NANO¿ 2ND GEN PEN NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·June 17, 2022

    BD NANO¿ 2ND GEN PEN NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·June 17, 2022

    PEN NDL 32G 4MM PRO

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·August 17, 2021

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code CBK·February 5, 2013

    TI PANGEA LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code NKB·March 1, 2011

    PANOCELL-10

    FDA Adverse Event
    IMMUCOR, INC.·Product code KSZ·March 17, 2008

    BD PEN NDL 32G 4MM PRO

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·October 14, 2021

    BD PEN NDL 32G 4MM PRO

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·September 28, 2021

    ECHELON ENDOPATH STAPLER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 1, 2025

    uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Ulrich Medical USA Inc·May 3, 2017

    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