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

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    FDA 510(k)
    FDA Class 2 ·Dental

    BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BACTEC MGIT 960 SIR KITS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    AVISTA MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 30, 2024

    GEM SPLT SET Y-EXT BCXCHK 282CM (50EA/CS)

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 6, 2014

    GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS)

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 6, 2014

    GEM SPLT SET Y-EXT BCKCHK 282CM

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 23, 2014

    GEM SPLT SET Y-EXT BCKCHK 282CM (50EA/CS)

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·November 27, 2013

    KAINOX SL 65/18

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVY·April 29, 2013

    NEXGEN COMPLETE KNEE SOLUTION T-HANDLE

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code LXH·March 31, 2011

    CLARION

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS, LLC·Product code MCM·March 5, 2008

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·May 6, 2022

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·June 30, 2025

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·September 19, 2023

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·March 26, 2022

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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