BEUDAMED
    18 results · 32ms · Sources: EU EUDAMED, US FDA

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    RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743687·ACHIMED ACHILLES SUPP SILVER V

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036019709·

    COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    UNKNOWN PENCIL

    FDA Adverse Event
    Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·January 5, 2021

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 25, 2013

    LEAD MODEL UNKNOWN

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·March 11, 2011

    COMP RVS HMRL TI TRAY 44MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PAO·August 19, 2014

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·September 10, 2015

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code EZW·March 5, 2013

    UNK_ULTRACISION HARMONIC FOCUS

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 1, 2025

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·November 4, 2020

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·September 12, 2021

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code NEW·September 12, 2021

    Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·December 11, 2013

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    FDA Adverse Event
    Death ·HEARTWARE, INC.·Product code DSQ·November 4, 2020

    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