BEUDAMED
    26 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.

    FDA Enforcement
    Class II ·Terminated·Convatec Inc.·March 26, 2014

    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

    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

    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

    Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.

    FDA Enforcement
    Class II ·Terminated·JAS Diagnostics Inc.·December 24, 2014

    Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.

    FDA Enforcement
    Class II ·Terminated·JAS Diagnostics Inc.·July 2, 2014

    Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.

    FDA Enforcement
    Class II ·Terminated·JAS Diagnostics Inc.·July 12, 2017

    Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. dba Mindray North America·October 24, 2018

    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

    Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.

    FDA Enforcement
    Class II ·Terminated·Jas Diagnostics/Drew Scientific·May 4, 2016

    7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids

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

    7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 Accessory device used to administer medical fluids

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

    REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits

    FDA Enforcement
    Class II ·Terminated·Medical Components, Inc dba MedComp·March 6, 2013

    Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·April 4, 2018

    CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep

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

    CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep

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

    Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.

    FDA Enforcement
    Class II ·Terminated·Vygon Corporation·March 20, 2013

    Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk; A400150 - Bond Elut EMS Card 50/Pk; A400150K - Bond Elut DMS Card BULK 500/pk; A400150SK - Bond Elut DMS Card Starter Kit A42001 - Bond Elut MDS Card Accessory Pack Product Usage: For use in the analysis of dried blood spots and other biological matrices in research applications for drug metabolism pharmacokinetics/ absorption, distribution. metabolism and excretion (DMPK/ ADME) studies.

    FDA Enforcement
    Class II ·Terminated·Agilent Technologies, Inc.·April 12, 2017