BEUDAMED
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    BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR

    FDA 510(k)
    FDA Class 2 ·Hematology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450382981·

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361012122·PedFuse Respond, SLD, 8.0mm x 60mm

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033449028·

    EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    0009613348-2024-012960

    FDA Adverse Event
    Injury ·INSTITUT STRAUMANN AG·Product code DZE·September 30, 2024

    TARGET ADAPTER T2 SCN

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 21, 2012

    INFUSION DEVICES - UNKNOWN

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·October 16, 2024

    INFUSION DEVICES - UNKNOWN

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·October 16, 2024

    REPLACEMENT HEART VALVE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DYE·March 20, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code LWS·March 10, 2011

    EASY LOAD INSERTER

    FDA Adverse Event
    Injury ·BAUSCH & LOMB·Product code MSS·March 13, 2008

    INTELLIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 12, 2023

    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

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025