BEUDAMED
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    ADVANCED LUNG ANALYSIS-1

    FDA 510(k)
    FDA Class 2 ·Radiology

    Affinity™ Heavy Body RS Mega Mix 380mL

    FDA UDI
    DEN-MAT HOLDINGS, LLC·00359883005993·VPS Impression Material

    Affinity™ Heavy Body RS Mega Mix 380ml

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172017039·VPS Impression Material

    Brasseler USA

    FDA UDI
    Peter Brasseler Holdings, LLC·00887919993803·ACCUR8 VOLUME MTRL HB RS 380ML

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450480533·

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033483145·

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·January 8, 2026

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL UM-D·Product code FPA·February 2, 2026

    SHIELDING NEEDLE HOLDER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    D.SIGN 30

    FDA 510(k)
    FDA Class 2 ·Dental

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·March 20, 2013

    HEARTMATE II LVAD

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·March 8, 2011

    SPRINT FIDELIS

    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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    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