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

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    icotec Anterior Cervical Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EarQ

    FDA UDI
    Oticon A/S·05707131353719·G40 S, MINIRITE T 312 2.4G C093 EARQ

    19 GA PLASTIC REINFORCED EPIDURAL CATHETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VALVE CONDUIT CONTEGRA

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code MWH·October 27, 2014

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    LINOX SMART PROMRI S DX 65/15

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVY·July 2, 2013

    INTRATHECAL CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·January 6, 2016

    INTRATHECAL CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·January 6, 2016

    INTRATHECAL CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·January 6, 2016

    INTRATHECAL CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·January 6, 2016

    DA VINCI SURGICAL SYSTEM

    FDA Adverse Event
    Death ·INTUITIVE SURGICAL,INC.·Product code NAY·May 15, 2015

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·March 25, 2016

    EXCOR BLOOD PUMP PU VALVES;30 ML;IN/OUT 9 MM

    FDA Adverse Event
    Malfunction ·BERLIN HEART GMBH·Product code DSQ·October 1, 2015

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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