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

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    SAUFLON MULTIPURPOSE SOLUTION - NO RUB

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922

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

    VIVANT MEDICAL BIOPSY MARKER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AIMING ARM/ RADIOLUCENT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code JDS·October 8, 2024

    OPERA

    FDA Adverse Event
    Malfunction ·ARJO MED AB LTD.·Product code FSA·March 28, 2013

    7600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 7, 2011

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JJE·April 15, 2008

    BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿

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

    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

    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