BEUDAMED
    10 results · 35ms · Sources: EU EUDAMED, US FDA

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    PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MICROPERFORATION INSTRUMENT

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    PLUS PIVOT LINK UNIVERSAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 26, 2024

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 22, 2013

    HAMILTON-G5

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL INC.·Product code CBK·April 14, 2011

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 2, 2008

    Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; 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