BEUDAMED
    19 results · 20ms · 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 ×

    A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Axiom® Hacienda Sump®

    FDA UDI
    AXIOM MEDICAL, INCORPORATED·M6651111660·Dual Lumen, Mediastinal, Round, Silicone, Round...

    K181166

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·December 2, 2022

    4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    HT70 PLUS VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS INC.·Product code CBK·June 2, 2017

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022

    PKS SUPERPLUS GENERATOR

    FDA Adverse Event
    Injury ·GYRUS MEDICAL LTD.·Product code GEI·May 8, 2013

    ACRYSOF IQ TORIC

    FDA Adverse Event
    Other ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·May 26, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 8, 2018

    5.5 EXP VERSE UNITIZED SET SCR

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·December 19, 2019

    5.5 EXP VERSE SCR 6.0X45

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·December 19, 2019

    Artis Q.zen ceiling, Model Number 10848354

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 8, 2023

    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

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018