BEUDAMED
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    CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481

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

    ORTHO

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750007837·ORTHO® Antibody Enhancement Solution

    ERA 3.25MM IMP 0DEG MICRO HEAD 13X1MM ACID ETCH, Ti

    FDA UDI
    STERNGOLD DENTAL LLC·00841549109751·Designed for both transitional and long-term de...

    BLO2X OXYGEN BLOCKER

    FDA 510(k)
    FDA Class 2 ·Dental

    OmniTom Elite

    FDA 510(k)
    FDA Class 2 ·Radiology

    COBLATOR II

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code GEI·May 7, 2014

    RIATA ACTIVE FIXATION

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

    TRIAGE CARDIAC PANEL 25 TEST

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC·Product code NBC·November 12, 2010

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

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

    DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

    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