BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    LAPARETTE, MODEL LAP J L S H N

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Natus

    FDA UDI
    XLTEK·00382830058209·IP Alarm Controller, Box

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·December 20, 2022

    COMPRESSIBLE LIMB SLEEVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000

    FDA 510(k)
    FDA Class 2 ·Hematology

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 27, 2013

    INNOVA 2000

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS, LLC·Product code OWB·January 17, 2014

    TERUMO CDI 540 CALIBRATOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·February 24, 2011

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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