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

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    Filters Classification: Class Iii ×

    OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)

    FDA Enforcement
    Class III ·Ongoing·POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC·November 26, 2025

    X5-1c Transducer Probe

    FDA Enforcement
    Class III ·Ongoing·Philips Ultrasound, Inc·September 3, 2025

    Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT

    FDA Enforcement
    Class III ·Ongoing·Penner Patient Care, Inc.·March 18, 2026

    BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·October 17, 2018

    BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·May 9, 2018

    PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·November 2, 2016

    PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec &#38 Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·November 2, 2016

    BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·July 23, 2014

    BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·July 10, 2013

    BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX)  I Plate Product Usage: Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. Chocolate II Agar is an enriched medium for the isolation and cultivation of Neisseria species.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·May 3, 2017

    BD MAX DNA MMK Lab Use, catalog no. 442828

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·May 9, 2018

    DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.

    FDA Enforcement
    Class III ·Terminated·BC Group International Inc·December 30, 2015

    BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID broth tube inoculum, add AST indicator to the AST broth tube and transfer an aliquot of ID broth to AST broth tubes, as required for preparing samples for use on the BD Phoenix" system, which performs identification and susceptibility testing

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·December 13, 2017

    Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.

    FDA Enforcement
    Class III ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    AcoSound. Model Number: LW12-BTE-M

    FDA Enforcement
    Class III ·Ongoing·HANGZHOU ACOSOUND TECHNOLOGY CO., LTD.·June 25, 2025

    Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation

    FDA Enforcement
    Class III ·Terminated·Dannoritzer Medizintechnik GmbH & Co. KG·October 10, 2018