BEUDAMED
    13 results · 39ms · Sources: EU EUDAMED, US FDA

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    RANFAC BONE MARROW ASPIRATION NEEDLE

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

    E-BASIC SINGLE BREAST PUMP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JGS·February 11, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014

    APOGEE

    FDA Adverse Event
    Injury ·UNK·Product code FTL·May 22, 2013

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011

    HANCOCK AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DYE·November 7, 2019

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 2, 2026

    STEM: AMISTEM H HA COATED STD STEM SIZE 3

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 1, 2023

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

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