BEUDAMED
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    ACTIVAPATCH

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065753·INTRAORAL ELASTICS 6,5 oz 5/16" blue

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450462683·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450466353·

    NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    VIDAS TESTOSTERONE (TES), MODEL 30 418

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 17, 2025

    AS3000 ANESTHESIA SYSTEM

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code BSZ·April 30, 2013

    NATURALYTE

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 5, 2014

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC·Product code CBK·May 4, 2011

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 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