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

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    DEFINIUM 5000 X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16

    FDA 510(k)
    FDA Class 2 ·Immunology

    BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 230733¿and 231274¿

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Co.·February 14, 2024

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·September 3, 2018

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 17, 2013

    MESH-COMPOSIX KUGEL

    FDA Adverse Event
    Death ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·June 19, 2008

    WINGSPAN STENT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - FREMONT·Product code NJE·April 19, 2011

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015