BEUDAMED
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    QFLOW 500 PERFUSION MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033483008·

    EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN LABELING (200

    FDA 510(k)
    FDA Class 1 ·General Hospital

    WELCH ALLYN 11800 OPTHALMOSCOPE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 19, 2025

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 19, 2025

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 19, 2025

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 25, 2024

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 20, 2013

    C/M INTERCHANGABLE HUMERAL ASSEMBLY

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDC·March 8, 2011

    SPRINT QUATTRO SECURE

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

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·September 13, 2016

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·September 15, 2016

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·September 15, 2016

    CADD CASSETTE RESERVOIR

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FPA·June 22, 2020

    CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024

    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