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

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    SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS

    FDA 510(k)
    FDA Class 2 ·Neurology

    Elastex PF Nitrile Glove

    FDA UDI
    HENRY SCHEIN, INC.·00304040056967·Elastex PF Nitrile Glove LARGE

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H658103330017·ELASTEX GLOVE PF LF

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033341·Baltic Denture System BDLoad BDLoad ↓ Ln6 PLSEu...

    EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    RUNWAY GUIDE CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013

    OSSEOTITE CERTAIN IMPLANT 4 X 11.5MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·December 18, 2023

    COBAS C111

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 3, 2013

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·March 22, 2011

    2531468-2008-00001

    FDA Adverse Event
    Other ·Product code IKX·April 7, 2008

    NUVASIVE HELIX ACP SYSTEM

    FDA Adverse Event
    Malfunction ·NUVASIVE, INC.·Product code KWQ·June 1, 2022

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021