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    IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450530320·

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·January 19, 2026

    Phantom® Fibula Nail System

    FDA UDI
    Paragon 28, Inc.·00889795134332·3.5mm x 66mm, Threaded Peg, Ti

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033508435·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033508442·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033508428·

    VenSure 4D Balloon Dilation System

    FDA UDI
    Fiagon GmbH·04260759931680·Balloon Dilation system as a set including navi...

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNDEO SYRINGE PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code MEA·October 8, 2009

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·March 20, 2013

    PARADYM

    FDA Adverse Event
    Malfunction ·SORIN BIOMEDICA CRM S.R.L.·Product code NIK·March 10, 2011

    SPRINT

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2008

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015