BEUDAMED
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    ACID PHOSPHOTASE REAGENT TEST AND KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    COMOACT ULTRASONIC NEBULIZER, MODEL 3060

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BRAVO PH MONITORING SYSTEM AND ACCESSORIES

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 15, 2023

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 8, 2014

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·November 12, 2010

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·July 26, 2024

    NSK

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EFB·September 17, 2025

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 18, 2019

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 18, 2019

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 18, 2019

    Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·November 12, 2025

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    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

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017