BEUDAMED
    418 results · 12ms · Sources: EU EUDAMED, US FDA

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    Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of standard curved suture needles, similar to open abdominal suturing.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 14, 2017

    bioMrieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code JST·January 23, 2018

    The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant fastidious organisms. The VITEK 2 NH identification card is a single-use disposable. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·June 20, 2018

    bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·August 29, 2018

    Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems, Regulation Number 21 CPR 892.1000, Regulatory Class II, Product Code 90-LNH and was cleared with K032490

    FDA Recall
    Terminated ·Toshiba American Med Sys Inc·Product code LNH·October 12, 2005

    Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc. Biopsy Needle Kit (9733068) Note: This device is an accessory to your StealthStation System. . . The Biopsy Needle is a presterilized , single-use, side-cutting needle for cranial tissue biopsies. CE 0344 Rx Only 2017-05 9733068-01 Medtronic Navigation, Inc.

    FDA Enforcement
    Class I ·Terminated·Medtronic Navigation, Inc.·January 9, 2019

    7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009