BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    Pulse Oximeter (WS20A)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Symmetry Surgical

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482060902·Micro Instrument Tray 8" X 8 1/2" X 1 1/4"

    MINI L.E.D. OEM MODULE

    FDA 510(k)
    FDA Class 2 ·Dental

    Q-STATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 10, 2014

    NAVISTAR THERMOCOOL

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER·Product code OAD·August 28, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·July 22, 2013

    DELTA CER INSERT 32ID X 50OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code MRA·May 28, 2024

    Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S.¿ 5000TS Product Description: A.T.S 5000TS Tourniquet Systems Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Zimmer Surgical Inc·February 4, 2026

    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 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

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014