BEUDAMED
    22 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    DAUM-LECTRIC MRI DRILLING MACHINE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    OneTouch Ultra2

    FDA UDI
    LifeScan Europe GmbH·00353885000277·OneTouch Ultra2 Blood Glucose Monitoring System...

    Reicodent

    FDA UDI
    devemed GmbH·04061644049684·Needle holder "Lichtenberg-Ryder" | 16.5 cm cur...

    Reicodent

    FDA UDI
    devemed GmbH·04061644049677·Needle holder "Lichtenberg-Ryder" | 16.5 cm str...

    5192 FRONTALIS SUSPENSION SET

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code HNM·December 18, 1998

    REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01

    FDA 510(k)
    FDA Class 2 ·General Hospital

    T:FLEX INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·August 9, 2018

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code DYB·April 11, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·April 8, 2025

    TCI IP LEFT VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Death ·THERMO CARDIOSYSTEMS INC.·Product code DSQ·March 11, 1998

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 24, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    FDA Adverse Event
    Injury ·HOLOGIC·Product code MNB·March 15, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011

    MICROSTAAR INJECTOR CARTRIDGE

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code KYB·March 27, 2008

    INTROCAN SAFETY®

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·March 20, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·April 10, 2025

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code DYB·March 18, 2026

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014