BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GS FIXTURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    TRABECULAR METAL TIBIAL CONE AUGMENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    1823260-2017-00269

    FDA Adverse Event
    Malfunction ·February 10, 2017

    1823260-2017-01418

    FDA Adverse Event
    Malfunction ·July 10, 2017

    COBAS 4000 C (311) STAND ALONE SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·February 15, 2017

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 17, 2013

    ENDOPATH** XCEL* TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·July 22, 2011

    BRAVO

    FDA Adverse Event
    Malfunction ·ARIZONA DEVICE MANUFACTURING·Product code FFT·September 19, 2008

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

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