BEUDAMED
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    ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 2359

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902954689·CDHL INST TRAY 2

    MedGyn Shaatz w/drain #1

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803050121·Shaatz pessary is used to treat uterine prolapse.

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450142523·

    Invotec Tracheal T-Tube

    FDA UDI
    INVOTEC INTERNATIONAL, INC.·00818501020102·Invotec Tracheal T-Tube, Non-Sterile, 12.0cm Long

    Aurora Anterior Lumbar Plate

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215125509·

    TLS 5.0

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B0301000501210·Osteotome, 5mm

    IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB

    FDA 510(k)
    FDA Class 2 ·Immunology

    STERILE BUTTON PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HARMONIC SCALPEL 5MM DISSECTING HOOK

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, INC.·Product code KNS·May 5, 1997

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 23, 2020

    ENERGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 10, 2013

    ROSS LAPAROSCOPIC JEJUNOSTOMY KIT

    FDA Adverse Event
    Injury ·ABBOTT NUTRITION CONSUMER RELATIONS·Product code KNT·May 20, 2008

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 1, 2011

    BD FACS 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·June 30, 2020

    BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·May 8, 2025

    BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 28, 2025

    CYLINDRICAL CHPV

    FDA Adverse Event
    Injury ·Product code JXG·July 12, 2016

    BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

    FDA Enforcement
    Class II ·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020

    BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

    FDA Enforcement
    Class II ·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020