BEUDAMED
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    GENZYME OSOM TRICHOMONAS RAPID TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033864·Baltic Denture System BDLoad BDLoad Lw6 PLSEbi...

    MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INJEX 50 SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·May 4, 2018

    ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM

    FDA Adverse Event
    Other ·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005

    13X75MM,1.8ML BD VACUTAINER®PLUS PLASTIC CITRATE TUBE, BD HEMOGARD¿ CLOSURE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·October 9, 2017

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 3, 2013

    HEMODIALYSIS KIT: 2-L 15 FR X 24 CM

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code MSD·February 11, 2011

    ZENITH AAA ILIAC LEG GRAFT

    FDA Adverse Event
    Injury ·COOK, INC.·Product code MIH·April 25, 2008

    UNKNOWN PFM-R DISTAL STEM

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code JDI·March 13, 2018

    Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·November 30, 2022

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013