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

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    MALE CIRCUMCISION KITS:RAPIDECLAMP

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

    MONICA IF24

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

    REALSEAL XT SEALER

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2025

    BATHLIFT BLISS RECLINER US AB

    FDA Adverse Event
    Malfunction ·HANDICARE·Product code FSA·May 23, 2013

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·May 26, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 3, 2008

    ESOPHYX Z

    FDA Adverse Event
    Injury ·ENDOGASTRIC SOLUTIONS, INC.·Product code ODE·June 22, 2017

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 30, 2013

    Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    PKG, 5MM X 45CM, INSERT, METZENBAUM CURVED SCISSORS, LONG JAW, P/N 0250080752 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014