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

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    CLAVE NEUTRON

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Digital Analogue WP

    FDA UDI
    RP - CONEXOES RESTAURADORAS LTDA·07901059074635·

    Bur PM2-70 50K Diam C Ø4.5

    FDA UDI
    Bien-Air Surgery SA·07630055503893·

    Plasti-Products

    FDA UDI
    PLASTI-PRODUCTS INC·10797876104341·sharps container, red vertical entry,14qt

    Sentiero Desktop

    FDA UDI
    PATH medical GmbH·04260223142451·Sentiero Desktop (Tymp Screening)

    Sentiero Desktop

    FDA UDI
    PATH medical GmbH·04260223142468·Sentiero Desktop (Tymp Diagnostic)

    AuDX PRO FLEX Device with touchscreen

    FDA UDI
    PATH medical GmbH·04260223143304·AuDX PRO Flex branded Sentiero Desktop

    Sentiero Desktop (Auditdata)

    FDA UDI
    PATH medical GmbH·04260223142819·Sentiero Desktop (Tymp Diagnostic)

    Bicon Impression Component

    FDA UDI
    BICON, LLC·00813110023728·3.0mm Two-Part Implant Level Impression Kit

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 30, 2025

    HM-LAMP II

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OPTETRAK B-SERIES TOTAL KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    microTargeting™ Drive Mount and Guide

    FDA UDI
    FHC, INC.·00873263004340·Drive Mount and Guide for microTargeting Drive

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 26, 2026

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 26, 2019

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 8, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 18, 2014

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·May 13, 2011

    Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·March 20, 2013

    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