BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bur PM2-70 50K Steel Ø6.0 St

    FDA UDI
    Bien-Air Surgery SA·17630055503845·

    Digital Analogue NP

    FDA UDI
    RP - CONEXOES RESTAURADORAS LTDA·07901059074574·

    KENEX

    FDA UDI
    KENEX (ELECTRO-MEDICAL) LIMITED·05055449414067·100/428 Skirt Hook (pair)

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319736661·Wire Cutting Scissors 4-3/4" (11.9cm), curved t...

    DIXI 2

    FDA 510(k)
    FDA Class 2 ·Dental

    ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    UNKNOWN ENDO GIA SULU

    FDA Adverse Event
    Injury ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·January 4, 2022

    PANEL PHOENIX NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·August 26, 2025

    PANEL PHOENIX NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·August 26, 2025

    PANEL PHOENIX NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·August 26, 2025

    ADAPTER SLEEVES 12/14 +2

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 8, 2013

    ENCORE BIPOLAR SYSTEM

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code KWB·August 6, 2008

    SPIDER CERVICAL PLATING SYSTEM 4X14MM SCREW

    FDA Adverse Event
    Injury ·X-SPINE SYSTEMS, INC.·Product code KWQ·May 16, 2011

    INVICTUS SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Injury ·ALPHATEC SPINE INC·Product code HXX·August 10, 2020

    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·April 23, 2025

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020