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

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    Palm Care Latex Examination Powder Free Gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112625·BARRON CORNEAL PUNCH 7.75MM

    THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·March 14, 2014

    BLOOD PUMP PU VALVES 10 ML, IN/OUT Ø6 MM

    FDA Adverse Event
    Injury ·BERLIN HEART GMBH·Product code DSQ·October 17, 2023

    PROMUS PREMIER?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·October 27, 2014

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code MMH·August 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

    EXCOR®

    FDA Adverse Event
    Injury ·BERLIN HEART GMBH·Product code DSQ·October 17, 2023

    MEDTRONIC NAVIGATION

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC·Product code HAW·August 17, 2023

    ALTRX +4 NEUT 32IDX48OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·June 5, 2023

    O-ARM IMAGING SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OXO·August 18, 2023

    ENDURANT STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·April 5, 2023

    SELECTSECURE MRI SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code NVN·June 22, 2023

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025