BEUDAMED
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    ARGYLE SUCTION CANISTER W/DISP. LINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Y-ADAPTER

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 12, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·October 23, 2012

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER.

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·August 17, 2010

    GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 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

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025