BEUDAMED
    17 results · 24ms · 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.

    Permatage XT Settable Bone Putty

    FDA 510(k)
    FDA Class 2 ·Neurology

    Symmetry Surgical

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482002957·CERVICAL DRILL TIP 10

    Disposable Microwave Therapeutic Antennas

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

    NuVasive® VersaTie System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·May 25, 2023

    INFUSO.R.

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 23, 2011

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·November 19, 2014

    TRABECULAR METAL SHELL WITH CLUSTER HOLES

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWZ·July 31, 2013

    ATTAIN OTW

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code LWP·August 15, 2017

    Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional catheters.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 6, 2019

    IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·February 22, 2022

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON RESEARCH. LTD./HUNTINGTON·Product code HQL·January 30, 2013

    UNKNOWN PLATES

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code HRS·August 25, 2020

    UNKNOWN SCREWS

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code HWC·August 25, 2020

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·April 14, 2020

    IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code EZW·February 22, 2022

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024