BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450476888·

    BIOMET EXTERNAL WRIST PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ST AIA-PACK CA 19-9

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 3, 2026

    ASPHERE M SPEC 12/14 40 -2

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 29, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 10, 2011

    PLUM XLMD PUMP

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·July 24, 2008

    VERCISE CARTESIA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code NHL·May 2, 2024

    CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012