BEUDAMED
    73 results · 12ms · 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 Status: Terminated ×

    JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.

    FDA Enforcement
    Class II ·Terminated·Stanmore Implants Worldwide Ltd.·September 13, 2017

    JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.

    FDA Recall
    Terminated ·Stanmore Implants Worldwide Ltd. Centennial Park·Product code KRO·July 4, 2017

    BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JTS·April 14, 2020

    Difco (TM) BBL (TM) Gram Crystal Violet, 250 mL bottles in packs of four, catalog # 212525 and 3.8 L bottles, catalog # 212526, staining reagent.

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JTS·September 29, 2004

    BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code JTS·April 12, 2012

    Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

    FDA Recall
    Terminated ·BioMerieux SA Chemin De L'Orme Marcy L'Etoile France·Product code JTS·March 23, 2018

    Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code JTS·April 12, 2012

    Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.

    FDA Recall
    Terminated ·Remel Inc·Product code JTS·October 29, 2014

    BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JTS·April 14, 2020

    BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JTS·April 14, 2020

    Parks Medical Ultrasonic Doppler Flow Detector, Model 811-BTS (finished assembly without accompanying probes), Parks Medical Electronics, Inc., Aloha, OR 97007

    FDA Recall
    Terminated ·Parks Medical Electronics Inc·Product code DPW·November 8, 2007

    IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded room to facilitate intraoperative and multi room use.

    FDA Recall
    Terminated ·Deerfield Imaging, Inc.·Product code LNH·April 4, 2018

    Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).

    FDA Recall
    Terminated ·Deerfield Imaging·Product code LNH·February 10, 2016

    Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO

    FDA Enforcement
    Class II ·Terminated·Clinical Innovations, LLC·February 4, 2015

    The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.

    FDA Enforcement
    Class II ·Terminated·Clinical Innovations, LLC·October 21, 2015

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

    FDA Recall
    Terminated ·JAS Diagnostics Inc.·Product code CGA·April 7, 2014

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

    FDA Recall
    Terminated ·JAS Diagnostics Inc.·Product code GKZ·April 21, 2017

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

    FDA Recall
    Terminated ·JAS Diagnostics Inc.·Product code CFR·October 23, 2014

    StemPro¿ MSC SFM CTS"

    FDA Enforcement
    Class II ·Terminated·Life Technologies Corporation·November 13, 2019

    ACL TOP 300 CTS, automated coagulation laboratory instrument.

    FDA Enforcement
    Class II ·Terminated·Instrumentation Laboratory Co.·July 23, 2014