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

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    SYLE SMARTIP

    FDA 510(k)
    FDA Class 1 ·Dental

    Bur PM2-150 80K MstickD Ø4.0St

    FDA UDI
    Bien-Air Surgery SA·17630055515015·

    SafeOp

    FDA UDI
    ALPHATEC SPINE, INC.·00190376235493·SafeOp Neural Informatix System Cable, Left Acq...

    VersaTrode™

    FDA UDI
    GRAPHIC CONTROLS ACQUISITION CORP·10813150021156·

    VersaTrode™

    FDA UDI
    GRAPHIC CONTROLS ACQUISITION CORP·10009336008473·Adult General Purpose ECG Electrodes

    Monoblock Tibial Trial UC Insert

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215043308·

    N/A

    FDA UDI
    Doppkon GmbH & Co. KG·04262494463365·Kerrison Punch length 200mm, width 2mm, 90° up...

    AT WORK DRUG TEST, MODEL 9177T AWT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·November 19, 2024

    EPIC¿ VALVE (AORTIC)

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code LWR·October 2, 2025

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SWINFORD·Product code KDI·September 24, 2015

    SUR-FIT NATURA DURAHESIVE FLEXIBLE SKIN BARRIER W/FLANGE W/WHITE TAPE COLLAR & C

    FDA Adverse Event
    Injury ·CONVATEC DOMINICAN REPUBLIC, INC.·Product code EXE·September 12, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 12, 2011

    DISPOSABLE STERILE HIGH TEMPERATURE ELECTROCAUTERY (HTC) F7244

    FDA Adverse Event
    Injury ·FIAB SPA·Product code GEI·October 12, 2023

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

    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

    INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025

    ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025