BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    PMR-2 PURITAN MANUAL RESUSCITATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450160688·

    NIPRO SAFETOUCH SAFETY FISTULA NEEDLE

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

    STRYKER LED LIGHTSOURCE

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

    GEMSTAR PAIN MGE SNG

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 21, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 1, 2007

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·October 24, 2012

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 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

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018