BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    EMIT D.A.U. LOW AND MEDIUM CALIBRATORS B

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083010645·Fixed, 10 electrode, CS, 2mm electrode spacing

    Printed Lower ROC Pack for Herbst LL7 8mm

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199015730·

    LINER FOR METAL BACK GLENOID STANDARD

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·November 7, 2022

    ACCUSCULPT II LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES

    FDA 510(k)
    FDA Class 2 ·Microbiology

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·October 28, 2025

    SAPPHIRE MULTITHERAPY INFUSION PUMP KIT

    FDA Adverse Event
    Injury ·Q CORE MEDICAL LTD·Product code MEA·June 20, 2014

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 8, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·November 10, 2010

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·May 18, 2018

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·March 12, 2025

    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

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019