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

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    Bongo

    FDA 510(k)
    FDA Class 2 ·Dental

    KING SEPTEMS

    FDA Adverse Event
    Malfunction ·KING SEPTEMS·Product code LMA·November 1, 2012

    ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·July 3, 2019

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 20, 2013

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·July 27, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·January 25, 2021

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·December 10, 2019

    KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.

    FDA Enforcement
    Class II ·Ongoing·Genesee BioMedical, Inc.·June 6, 2018

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020