BEUDAMED
    20 results · 21ms · Sources: EU EUDAMED, US FDA

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    TI-MAX X TURBINE

    FDA 510(k)
    FDA Class 1 ·Dental

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·August 17, 2023

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·April 8, 2025

    TI-SU03 GC

    FDA Adverse Event
    Injury ·NAKANISHI INC. (NSK)·Product code EFB·May 26, 2015

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169605565·SPACER 2113655 OLIF25 20MM 18 DEG 18X55

    Comprehensive® Shoulder System

    FDA UDI
    Biomet Orthopedics, LLC·00887868267994·

    COMPREHENSIVE SHOULDER SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304467446·

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024494084·

    Stablecut®

    FDA UDI
    SYNVASIVE TECHNOLOGY, INC.·00846795004867·

    OCTANE-C INTERBODY FUSION DEVICE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HIRES 90K IMPLANT

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·May 10, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014

    ADVANTAGE SERIES 29

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·May 24, 2011

    VERSACROSS ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DYB·April 20, 2023

    COMPREHENSIVE REVERSE SHOULDER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PAO·January 4, 2018

    COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PAO·January 4, 2018

    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

    FDA Enforcement
    Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

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