BEUDAMED
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    SensorX

    FDA 510(k)
    FDA Class 2 ·Dental

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113813·VISCO CANNULA 27GA ANGLE 8MM

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113851·ARBISSER ANTERIOR CHAMBER CANNULA 30GA ANG 7MM

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113868·ROBINS ANTERIOR CHAMBER CANNULA, 30GA

    6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HTO·August 12, 2015

    AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·July 3, 2020

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·September 18, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·May 22, 2020

    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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025