BEUDAMED
    142 results · 77ms · 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.

    RHEAD STANDARD EXTENDED STEM, 6MM COLLAR, SIZE 2

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code KWI·December 21, 2015

    Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·May 4, 2016

    Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN, TX 78750 Product Usage: The device is intended as a cervical intervertebral disc replacement at one or two contiguous levels from C3 to C7 designed to maintain/restore segmental motion and disc height. MOBI-C distraction pins are inserted into the vertebral body below and above the disc that is to have the disc replacement. The pins are then attached to a locking retractor/distractor to open up the disc space in order to complete the discectomy and overall distraction during the surgery

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 26, 2019

    X-PAC

    FDA Adverse Event
    Injury ·EXPANDING INNOVATIONS, INC.·Product code MAX·April 15, 2024

    DS HEADNECK COIL 3.0T

    FDA Adverse Event
    Malfunction ·CARMA SALUD, S.L.·Product code MOS·December 10, 2018

    UNKNOWN TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code NTG·March 18, 2020

    UNKNOWN TALAR COMPONENT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HSB·March 24, 2020

    UNKNOWN TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HSB·March 24, 2020

    UNKNOWN TALAR COMPONENT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HSB·March 18, 2020

    UNKNOWN POLYETHYLENE LINER

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HSB·March 24, 2020

    TIBIAL COMP,SINGLECOATED US VERSION, MEDIUM

    FDA Adverse Event
    Injury ·STRYKER GMBH (MDR)·Product code NTG·July 1, 2015

    SLIDING CORE, UHMPWE,7MM

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code NTG·March 2, 2016

    SURGICAL STAINLESS STEEL SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAQ·January 4, 2023

    UNKNOWN_SELZACH_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HRS·July 30, 2015

    UNKNOWN_SELZACH_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code NTG·December 7, 2015

    UNKNOWN_SELZACH_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code NTG·December 8, 2015

    UNKNOWN TALAR COMPONENT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code NTG·March 24, 2020

    UNKNOWN TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HSB·March 24, 2020

    UNKNOWN TALAR COMPONENT

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code NTG·March 20, 2020

    UNKNOWN POLYETHYLENE LINER

    FDA Adverse Event
    Injury ·STRYKER GMBH·Product code HSB·March 24, 2020