BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30

    FDA 510(k)
    FDA Class 2 ·Dental

    FLOWLINE BIOPORE EPTFE VASCULAR GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CAPSUREFIX

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·April 10, 2013

    NEPTUNE ROVER WITHOUT SMOKE EVAC AND POWER POLE

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code FYD·February 25, 2011

    RINGLOC BI-POLAR CUP

    FDA Adverse Event
    Malfunction ·BIOMET, INC.·Product code JDI·May 16, 2008

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024