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

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    IM TOTAL FEMUR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033871·Baltic Denture System BDLoad BDLoad ↓ Mn6 PLSEu...

    Keyboard kit for wall or hanger

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06936415901752·

    KIT BD MAX EXT ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·October 15, 2021

    LAPAROSCOPIC HAND PORT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LIFEGUARD SAFETY INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·KYPHON, INC.·Product code NDN·June 23, 2006

    9611993-2025-033871

    FDA Adverse Event
    Injury ·NOBEL BIOCARE (PRODUCTION) AB·Product code DZE·January 13, 2025

    KIT BD MAX¿ EXT ENTERIC BACTERIAL PANEL

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·September 15, 2021

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·KYPHON, INC.·Product code NDN·June 20, 2006

    LEAD MODEL 303

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·April 3, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·March 17, 2011

    ZENITH AAA ILIAC LEG GRAFT

    FDA Adverse Event
    Injury ·COOK, INC.·Product code MIH·April 25, 2008

    NAIL, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JDS·July 25, 2016

    NAIL, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JDS·July 25, 2016

    Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·November 30, 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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013