BEUDAMED
    13 results · 34ms · Sources: EU EUDAMED, US FDA

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    I-STAT CARDIAC TROPONIN (CTNI) TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·February 14, 2012

    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

    POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN P

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MODIFICATION TO EBI XFIX DFS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD POSIFLUSH IV FLUSH NORMAL SALINE FILLED SYRINGE

    FDA Adverse Event
    Injury ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 19, 2023

    BD POSIFLUSH IV FLUSH NORMAL SALINE FILLED SYRINGE

    FDA Adverse Event
    Injury ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 19, 2023

    BD POSIFLUSH IV FLUSH NORMAL SALINE FILLED SYRINGE

    FDA Adverse Event
    Injury ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 19, 2023

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·April 2, 2013

    ACUITY CENTRAL MONITORING

    FDA Adverse Event
    Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code DSI·February 25, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

    TRIATHLON #4 PS INSERT 11MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·August 23, 2013

    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016