BEUDAMED
    21 results · 27ms · Sources: EU EUDAMED, US FDA

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    MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Leksell Stereotactic System

    FDA UDI
    Elekta Instrument AB·07340048305686·COUNTER SCALE WINDOW, SPARE

    ULTRACONCENTRATOR SYSTEM

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

    MEROGEL OTOLOGIC PACK

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 24, 2025

    PINN SECTOR HA ACET CUP 50MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code KWA·March 26, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011

    DASH 3000

    FDA Adverse Event
    Death ·GE HEALTHCARE·Product code MHX·March 27, 2008

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·August 26, 2021

    DERMABOND UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code MPN·April 12, 2023

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAN·April 12, 2023

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·October 26, 2022

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·April 12, 2023

    HEARTMATE 3 LVAS IMPLANT KIT

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·May 28, 2021

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NPT·August 7, 2025

    UNKNOWN_SPINE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER SPINE-US·Product code NKG·November 14, 2024

    UNKNOWN_SPINE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER SPINE-US·Product code NKG·November 14, 2024

    UNKNOWN_SPINE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER SPINE-US·Product code NKG·November 14, 2024

    CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37 C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·April 6, 2016

    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