BEUDAMED
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    Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113752·GIANNETTI POST CAPS CANNULA

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·November 5, 2020

    GELSPHERES EMBOLIC AGENT

    FDA 510(k)
    FDA Class 2 ·Neurology

    SEVEN IMPLANTS; BIOCOM IMPLANTS; LANCE IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    CAPSUREFIX NOVUS

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

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 18, 2014

    ECHELON*FLEX60

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 2, 2013

    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