BEUDAMED
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    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113882·VISCO INJECTION CANNULA 27GA

    Responsive Arthroscopy Thunderbolt System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113875·VISCO INJECTION CANNULA 30GA ANG 10MM

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113776·AIR INJECT CANNULA 27GA

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523148127·MIS Tibial Saw Block 0° Slope Left

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523148134·MIS Tibial Saw Block 5° Slope Left

    MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIFESTENT BILIARY ENDOPROSTHESIS

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

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 26, 2024

    EXTRACT SPECIMEN BAG, 10MM

    FDA Adverse Event
    Malfunction ·CONMED CORPORATION·Product code GCJ·July 13, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 17, 2014

    SECURA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·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

    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