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

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    UNI-PATCH ULTRASOUND COUPLING GEL

    FDA 510(k)
    FDA Class 2 ·Radiology

    ULTRAPOWER

    FDA UDI
    Conmed Corporation·10845854001462·ULTRAPOWER BUR, ROUND(COPPER), 9 MM

    Zavation

    FDA UDI
    Zavation LLC·00842166108509·PLIF-R 11x32-12

    Zavation

    FDA UDI
    Zavation LLC·00842166108547·PLIF-R 11x32-16

    Zavation

    FDA UDI
    Zavation LLC·00842166108530·PLIF-R 11x32-15

    Zavation

    FDA UDI
    Zavation LLC·00842166108523·PLIF-R 11x32-14

    Zavation

    FDA UDI
    Zavation LLC·00842166108516·PLIF-R 11x32-13

    AIRLIFE HEPA FILTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BONE BIOPSY NEEDLE

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

    MEDTRONIC LEAD

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DXY·October 8, 2021

    TRIMA ACCEL

    FDA Adverse Event
    Malfunction ·TERUMO BCT·Product code GKT·March 26, 2013

    CAPSUREFIX NOVUS

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

    ICY HOT HEAT THERAPY PATCH

    FDA Adverse Event
    Other ·CHATTEM, INC.·Product code IMD·March 27, 2008

    DHF 06 HEMOCONCENTRATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALY·Product code KDI·May 22, 2025

    MARATHON

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·March 18, 2022

    ONYX AVM

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·March 18, 2022

    BACT/ALERT I NST 100 BTLS - 259785

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX INC.·Product code MDB·March 4, 2024

    cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    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