BEUDAMED
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    BioFire RP2.1/RP2.1plus Control Panel M441

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112755·BARRON VACUUM PUNCH 7.5MM

    OnX Tough 2 - A2 - 3kg

    FDA UDI
    Sprintray, Inc.·00850070544559·SprintRay OnX Tough 2 is a tooth shade ceramic-...

    Tissue Holder

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111192·STEEL BASE FOR BARRON AAC

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112915·CORNEAL TREPHINE BLADE7.5MM

    LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NATUS BLUE LIGHT PHOTOTHERAPY UNIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2024

    ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

    FDA Adverse Event
    Malfunction ·CORDIS CORPORATION·Product code NTE·October 16, 2008

    SYMPHONY

    FDA Adverse Event
    Malfunction ·SORIN CRM·Product code NVZ·June 28, 2013

    LYNX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code FTL·August 5, 2011

    PIPELINE

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·February 24, 2022

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021