BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cook

    FDA UDI
    COOK INCORPORATED·00827002141889·Fascial Dilator

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 29, 2024

    MODIFICATION TO MALE TO MALE LUER ADAPTER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ENTERYX INJECTOR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 23, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 13, 2011

    TEMPERATURE ADAPTER CABLE ASSEMBLY

    FDA Adverse Event
    Malfunction ·SPACELABS HEALTHCARE·Product code MHX·July 1, 2008

    7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·July 26, 2017

    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