BEUDAMED
    103 results · 17ms · 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 Classification: Class Iii × Status: Terminated × Clear all

    Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.

    FDA Enforcement
    Class III ·Terminated·OraSure Technologies, Inc.·September 30, 2020

    VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestive heart failure.

    FDA Enforcement
    Class III ·Terminated·Biomerieux France Chemin De L'Or·September 21, 2016

    STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.

    FDA Enforcement
    Class III ·Terminated·Advanced Sterilization Products·December 11, 2013

    Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.

    FDA Enforcement
    Class III ·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·October 3, 2012

    Optilite IgG4 Kit Product Code: LK009.OPT.A

    FDA Enforcement
    Class III ·Terminated·The Binding Site Group, Ltd.·February 1, 2017

    VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468

    FDA Enforcement
    Class III ·Terminated·Ortho Clinical Diagnostics·May 6, 2020

    Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.

    FDA Enforcement
    Class III ·Terminated·Covidien LLC·May 22, 2013

    Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559

    FDA Enforcement
    Class III ·Terminated·Ivoclar Vivadent, Inc.·February 28, 2018

    Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501

    FDA Enforcement
    Class III ·Terminated·Ivoclar Vivadent, Inc.·February 28, 2018

    Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503

    FDA Enforcement
    Class III ·Terminated·Ivoclar Vivadent, Inc.·February 28, 2018

    Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502

    FDA Enforcement
    Class III ·Terminated·Ivoclar Vivadent, Inc.·February 28, 2018

    NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC.

    FDA Enforcement
    Class III ·Terminated·Nipro Medical Corporation·January 13, 2016

    VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Enforcement
    Class III ·Terminated·Ortho-Clinical Diagnostics·September 26, 2018

    Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD

    FDA Enforcement
    Class III ·Terminated·Clark Laboratories, Inc. (dba,Trinity Biotech USA)·September 21, 2016

    Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units

    FDA Enforcement
    Class III ·Terminated·C.R. Bard, Inc.·November 11, 2015

    Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with an active time scale and rate selector switch; product codes 2M8171 and 2M8171R. Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage: The Mini-Infuser System is designed for controlled intermittent administration of intravenous medication.

    FDA Enforcement
    Class III ·Terminated·Baxter Healthcare Corp.·September 5, 2012

    RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.

    FDA Enforcement
    Class III ·Terminated·Teleflex Medical·August 13, 2014

    enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above and enGen Custom 2.0 and Above; IVD

    FDA Enforcement
    Class III ·Terminated·Ortho-Clinical Diagnostics·July 20, 2016

    VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

    FDA Enforcement
    Class III ·Terminated·Ortho-Clinical Diagnostics·September 26, 2018

    VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems

    FDA Enforcement
    Class III ·Terminated·Ortho-Clinical Diagnostics, Inc.·November 24, 2021