BEUDAMED
    51 results · 18ms · 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 Enforcement ×

    Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·March 2, 2016

    Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·March 2, 2016

    Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·March 2, 2016

    Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·March 2, 2016

    Pressure Monitoring Set, C-PMS, G02838

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 10, 2020

    Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

    FDA Enforcement
    Class II ·Completed·Cook Incorporated·July 20, 2022

    Femoral Artery Pressure Monitoring Set

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 21, 2018

    Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are distributed with unique Catalog / Model Numbers: IFU00358, IFU00375, IFU00376, GR00526, IFU00520, IFU00526, IFU00593, IFU00614, M017475C001

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc·May 25, 2022

    Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 Custom Ultrasound Tray (e) CMS-2891-R1 Custom Safety Biopsy Tray (f) CMS-5798-R1 Custom Safety Biopsy Tray (g) CMS-2357R2 Custom Biopsy Tray (h) CMS-2540-R4 Custom Biopsy Tray

    FDA Enforcement
    Class II ·Terminated·Custom Assemblies Inc·August 30, 2017

    MICRO-X Rover Mobile X-ray System, # MXU-RV35

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·December 18, 2024

    The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)

    FDA Enforcement
    Class II ·Terminated·PMBS, LLC·April 6, 2016

    CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.

    FDA Enforcement
    Class II ·Ongoing·Custom Medical Specialties, Inc.·March 1, 2017

    3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136

    FDA Enforcement
    Class II ·Terminated·3M Company - Health Care Business·January 1, 2020

    7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids

    FDA Enforcement
    Class II ·Terminated·Churchill Medical Systems, Inc.·April 29, 2015

    CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution

    FDA Enforcement
    Class II ·Terminated·Custom Medical Specialties, Inc.·September 19, 2012

    Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.

    FDA Enforcement
    Class II ·Terminated·Churchill Medical Systems, Inc.·September 25, 2013

    Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring information from the medical devices. All these collected information can be displayed, printed, alarmed and recorded. Component: No

    FDA Enforcement
    Class II ·Ongoing·Edan Diagnostics·January 28, 2026

    CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep

    FDA Enforcement
    Class I ·Terminated·Custom Medical Specialties, Inc.·September 26, 2012

    CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep

    FDA Enforcement
    Class I ·Terminated·Custom Medical Specialties, Inc.·September 26, 2012

    Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk

    FDA Enforcement
    Class II ·Terminated·Stradis Medical, LLC dba Stradis Healthcare·December 29, 2021