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

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    ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by CTI Molecular Imagining, Inc. Sceptre and Sceptre XL (mobile systems) distributed by Hitachi Medical Systems America

    FDA Recall
    Terminated ·CTI PET Systems Inc·Product code KPS·April 5, 2005

    Ohmeda Giraffe SPOT PT Lite Phototherapy System

    FDA Recall
    Terminated ·Datex Ohmeda, Inc. dba GE Healthcare·Product code LBI·August 5, 2005

    GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·November 18, 2015

    Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 30mm, B=155mm, C=125mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-30-125.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MIH·December 20, 2004

    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