BEUDAMED
    171 results · 28ms · 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 FDA Recall ×

    DAC 044 115cm, Catalog: 90760

    FDA Recall
    Open, Classified ·Stryker Neurovascular·Product code DQY·April 23, 2024

    Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.

    FDA Recall
    Terminated ·Concentric Medical Inc·Product code DQY·August 19, 2015

    PDSIIVIO30IN(75CM)USP6-0(M0.7)D/AC-1

    FDA Recall
    Open, Classified ·Ethicon Endo Surgery, LLC·Product code NEW·March 7, 2025

    PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP

    FDA Recall
    Open, Classified ·Ethicon Endo Surgery, LLC·Product code NEW·March 7, 2025

    The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each catheter. The rotating hemostasis valve is typically y shaped with a female luer lock and a manual hemostasis valve. The female port allows for aspiration and contrast injections while the hemostasis valve allows direct arterial access when using other devices such as guidewires and/or interventional devices.

    FDA Recall
    Open, Classified ·Stryker Neurovascular·Product code DQY·April 3, 2024

    Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART.

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OEZ·February 21, 2025

    1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray

    FDA Recall
    Open, Classified ·American Contract Systems, Inc.·Product code OJG·March 22, 2022

    1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack

    FDA Recall
    Open, Classified ·American Contract Systems, Inc.·Product code OJH·March 22, 2022

    Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system

    FDA Recall
    Open, Classified ·NRT X-RAY A/S Birkegardsvej 16 Hasselager Denmark·Product code OWB·April 17, 2024

    Emission Computed Tomography System

    FDA Recall
    Terminated ·Adac Labs·Product code KPS·June 21, 2004

    Pinnacle3 Radiation Therapy Planning System, Version 6.6c Kit, Model Number 9200-0613C-ENG

    FDA Recall
    Terminated ·ADAC Laboratories·Product code MUJ·March 3, 2004

    Pinnacle3 Radiation Therapy Planning System, Version 7.0e Kit, Model Number 9200-9052A-ENG

    FDA Recall
    Terminated ·ADAC Laboratories·Product code MUJ·March 3, 2004

    Philips ADAC Pinnacle3 Version 6.4a Radiation Therapy Planning Software Package (Kit), Model Number 9200-0613B-ENG

    FDA Recall
    Terminated ·ADAC Laboratories·Product code MUJ·March 3, 2004

    Philips Pinnacle3 Version 6.4a Radiation Therapy Planning Software CD, Part Number 9104-0121B, Rev. A

    FDA Recall
    Terminated ·ADAC Laboratories·Product code MUJ·March 3, 2004

    Pinnacle3 Radiation Therapy Planning System, Version 7.0e CD, Part Number Part # 9104-2011A Rev. A

    FDA Recall
    Terminated ·ADAC Laboratories·Product code MUJ·March 3, 2004

    Pinnacle3 Radiation Therapy Planning System, Version 6.6c CD, Part Number 9104-0121C Rev. A

    FDA Recall
    Terminated ·ADAC Laboratories·Product code MUJ·March 3, 2004

    Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D SDA-SYS-3000-3D-UPS SDM-SYS-6000-3D-HTC SDM-05000-2D2 SDM-05000-3D2 SDM-SYS-6000-2D SDM-SYS-9000-3D

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code OTE·January 16, 2023

    SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code MUE·April 8, 2026

    18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;

    FDA Recall
    Open, Classified ·DAYE (ANNE'S DAY LTD) Biscuit Factory Business Complex 100 Drummond Road London United Kingdom·Product code HEB·February 17, 2025

    Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;

    FDA Recall
    Open, Classified ·DAYE (ANNE'S DAY LTD) Biscuit Factory Business Complex 100 Drummond Road London United Kingdom·Product code HEB·February 17, 2025