BEUDAMED
    15 results · 28ms · Sources: EU EUDAMED, US FDA

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    MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE

    FDA 510(k)
    FDA Class 2 ·Neurology

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690197089·Revision Knee Spiral Reamer- Hudson Short Flute...

    Mariner Outrigger

    FDA UDI
    Seaspine Orthopedics Corporation·10889981174118·L Con, Side-Loading, L, 16mm, 160mm

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code MNS·June 8, 2021

    DRX5000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER

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

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·February 15, 2022

    I-STAT CARTRIDGE

    FDA Adverse Event
    Injury ·ABBOTT POINT OF CARE·Product code CHL·August 8, 2014

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·Product code MNT·May 19, 2021

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 27, 2008

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 13, 2011

    Thermalon Sinus Compress, Item Number 24332

    FDA Enforcement
    Class II ·Ongoing·Bruder Healthcare Company, LLC·April 3, 2024

    i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code JGS·February 15, 2011

    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