BEUDAMED
    10 results · 22ms · Sources: EU EUDAMED, US FDA

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    ROCHE AMPLICHIP CYP450 TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PERICSCOPE, MODEL # PERISC1

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

    Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PLUM 4-PORT 15 FLTR 2CLV PE LINE 216CM

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 27, 2013

    ACUITY

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·April 9, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·March 25, 2011

    VITALITY 2 DR

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    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