BEUDAMED
    22 results · 23ms · Sources: EU EUDAMED, US FDA

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    ORAL BALANCE LIQUID/ GEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    Spacelabs Healthcare

    FDA UDI
    SPACELABS HEALTHCARE (WASHINGTON), INC·10841522120275·ANT,608-614 MHZ, UDI

    JP CAST 40

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNERGY HEAD/NECK COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    STELLARIS VISION ENHANCEMENT SYSTEM

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQC·February 5, 2026

    RU NOVOSIBIRSK

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 16, 2013

    ST JOSEPHS PHOENIX, AZ 1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA·Product code DWF·July 31, 2009

    RU NOVOSIBRIRSK

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·April 11, 2013

    STELLARIS ELITE VISION ENHANCEMENT SYSTEM

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQC·March 1, 2022

    RU NOVOSIBIRSK

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DWF·October 16, 2013

    CP87170 DE MUENCHEN

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 16, 2013

    SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code MND·April 18, 2011

    UNK

    FDA Adverse Event
    Injury ·UNK·Product code FGE·June 13, 2008

    CP87641 GB SOUTHAMPTON

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DWE·March 22, 2010

    STELLARIS POWER SUPPLY II

    FDA Adverse Event
    Malfunction ·BAUSCH + LOMB·Product code HQC·August 1, 2023

    D 100 PH.I.S.I.O. NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH RESERVOIR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTZ·March 28, 2017

    LOGIC TIBIA PS MOD INSRT SZ 6 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·November 13, 2023

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018

    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