BEUDAMED
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    Dental Electric Motor

    FDA 510(k)
    FDA Class 1 ·Dental

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180181854·STERILIZATION & STORAGE THERMOPLASTIC CONTAINER...

    XLP - CPRotector® Deluxe - Orange Nylon Pouch

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588030067·XLP - CPRotector® Deluxe - Orange Nylon Pouch

    Oph. Cystotomes

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113745·CCC CYSTOTOME FORMED 27GA

    Arena-C

    FDA UDI
    SPINEFRONTIER, INC.·00190361023081·Arena-C HA Straight 6mm 11x17 IBFD

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·September 18, 2020

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·September 11, 2020

    THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTROID HEMORRHOID MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BD MAX SYSTEM, BD MAX INSTRUMENT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code OOI·September 3, 2020

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 9, 2008

    GORE PROPATEN VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code DSY·June 24, 2013

    CAPSURE SP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021