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

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    HBA1C ENZYMATIC ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology

    MedGyn Pessary Cup w/support # 7

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803050178·Cup Pessary is used to treat uterine prolapse.

    Carts Lithium-ion Battery Kit

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904098708·

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·July 21, 2017

    SPERMICIDAL LUBRICATED MALE LATEX CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS·Product code LYJ·April 10, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·April 1, 2011

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·May 23, 2008

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024