BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONDEMAND3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    Prelude PF Patellae

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VSP SYSTEM

    FDA Adverse Event
    Injury ·3D SYSTEMS·Product code DZJ·December 18, 2020

    SCULPTRA

    FDA Adverse Event
    Other ·GLOBAL PHARMACOVIGILANCE AND EPIDEMIOLOGY/SANOFI-AVENTIS·Product code LMH·October 9, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 27, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 5, 2011

    GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·July 9, 2014

    GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare (China) Co., Ltd.·September 4, 2024