BEUDAMED
    15 results · 36ms · Sources: EU EUDAMED, US FDA

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    36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE

    FDA 510(k)
    FDA Unclassified ·Unknown

    GC FUJICEM

    FDA 510(k)
    FDA Class 2 ·Dental

    BD ULTRA-FINE¿ PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·September 14, 2018

    EVAC 70 XTRA HP COBLATOR II

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORP.·Product code GEI·May 6, 2021

    EDWARDS RETROFLEX 3 SHEATH

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYB·April 2, 2013

    AFFINITY BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code HDD·March 21, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 22, 2014

    CLEO® 90 INFUSION SET, 9MM CANNULA, 24" TUBING

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code FPA·November 14, 2016

    CLEO® 90 INFUSION SET, 9MM CANNULA, 24" TUBING

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code FPA·November 14, 2016

    i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

    FDA Enforcement
    Class II ·Terminated·Abbott Point Of Care Inc.·August 29, 2012

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    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