BEUDAMED
    33 results · 13ms · Sources: EU EUDAMED, US FDA

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    Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·March 19, 2021

    EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129

    FDA Enforcement
    Class II ·Terminated·Thera Test Laboratories, Inc.·September 8, 2021

    EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128

    FDA Enforcement
    Class II ·Terminated·Thera Test Laboratories, Inc.·September 8, 2021

    LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code JWH·May 19, 2021

    E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit

    FDA Enforcement
    Class I ·Terminated·E25Bio, Inc.·February 16, 2022

    Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

    Sterile Custom Packs to be used in surgical procedures.

    FDA Enforcement
    Class II ·Terminated·American Contract Systems·June 10, 2020

    Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DQK·April 19, 2021

    Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X

    FDA Recall
    Terminated ·Cordis Corporation·Product code LIT·July 19, 2021

    AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC.

    FDA Recall
    Terminated ·Sky Medical Supplies and Equipments LLC·Product code QKO·January 19, 2021

    GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional fluoroscopic x-ray systems.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code OWB·April 19, 2021

    Gentueri Viral Transport Medium (VTM), Sterile, IVD

    FDA Recall
    Terminated ·Gentueri Inc·Product code JSM·March 18, 2021

    Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA, Inc·Product code MAX·March 17, 2021

    Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA, Inc·Product code MAX·March 17, 2021

    Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.

    FDA Enforcement
    Class II ·Terminated·Orthofix Srl·January 3, 2018

    Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LLZ·March 19, 2021

    Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873), UDI: (01)00860003586303(10)1.2.0)

    FDA Recall
    Terminated ·Caption Health·Product code QIH·May 19, 2021

    The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code LJZ·February 8, 2021

    5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer

    FDA Recall
    Terminated ·Bard Access Systems Inc.·Product code LJS·May 19, 2021

    Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.

    FDA Recall
    Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code QAN·November 19, 2021