BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    SARNS 7000 MONITOR MODULE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209115358·

    ACUMED

    FDA UDI
    Acumed LLC·10806378046520·Ulnar Head Sizer

    ACTIVE ARRAY CATHETER, MODEL CS-2000

    FDA 510(k)
    FDA Class 2 ·Radiology

    ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2014

    RA CATH SET: 20 GA X 2-1 /2

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DQX·October 17, 2012

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 11, 2007

    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

    Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024