BEUDAMED
    130 results · 6ms · 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 × Classification: Class Iii × Clear all

    100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.

    FDA Enforcement
    Class III ·Terminated·Steris Corporation·September 12, 2012

    LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.

    FDA Enforcement
    Class III ·Terminated·Lighthouse For The Blind·April 17, 2013

    Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing

    FDA Enforcement
    Class III ·Terminated·Arrow International Inc·February 4, 2015

    Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.

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

    LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.

    FDA Enforcement
    Class III ·Terminated·Lighthouse For The Blind·April 17, 2013

    LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.

    FDA Enforcement
    Class III ·Terminated·Lighthouse For The Blind·April 17, 2013

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

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

    LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.

    FDA Enforcement
    Class III ·Terminated·Lighthouse For The Blind·April 17, 2013

    LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.

    FDA Enforcement
    Class III ·Terminated·Lighthouse For The Blind·April 17, 2013

    LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.

    FDA Enforcement
    Class III ·Terminated·Lighthouse For The Blind·April 17, 2013

    SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use of specific devices included in the kit.

    FDA Enforcement
    Class III ·Ongoing·Cardiac Assist, Inc·December 8, 2021

    Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512

    FDA Enforcement
    Class III ·Ongoing·Agilent Technologies, Inc.·July 20, 2022

    LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.

    FDA Enforcement
    Class III ·Terminated·Lighthouse For The Blind·April 17, 2013

    LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit.

    FDA Enforcement
    Class III ·Terminated·Lighthouse For The Blind·April 17, 2013

    FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.

    FDA Enforcement
    Class III ·Terminated·Bio-Rad Laboratories·October 30, 2013

    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

    APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens.

    FDA Enforcement
    Class III ·Terminated·Gen-Probe Inc·June 25, 2014

    Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc. The Sorting-Drive Plus Kit includes the Sorting-Drive 4.2.1 User Kit which includes the Sorting-Drive 4.2.1 Software DVD. . The Sorting-Drive software facilitates the Laboratory Information System (LIS) connection to AutoMate 2500 Family systems. .

    FDA Enforcement
    Class III ·Terminated·Beckman Coulter Inc.·November 7, 2018

    In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;

    FDA Enforcement
    Class III ·Ongoing·Abbott Molecular, Inc.·March 6, 2024

    Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits: HDPE plastic bottle, PP plastic caps. Bulk: PE plastic cube containers, PP plastic caps. Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only.

    FDA Enforcement
    Class III ·Terminated·Pointe Scientific, Inc.·September 23, 2015