BEUDAMED
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    EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    LCSU 4, 800 ml, RTCA Complete Unit

    FDA UDI
    Laerdal Medical AS·07045432088519·The LCSU 4 is a portable, electrically powered,...

    DESS dental smart solutions

    FDA UDI
    TERRATS MEDICAL SL.·08435457209768·Internal Hex Click

    Accessories, Soft Lens Products

    FDA Pre-Market Approval
    FDA Class 2 ·MURINE CONTACT LENS CLEANER

    UriSwab-Urine Collection, Transport and Preservation System

    FDA 510(k)
    FDA Class 1 ·Microbiology

    STRYKER ESSX WITH NAVIGATION MOUNT

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

    Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;

    FDA Enforcement
    Class II ·Ongoing·Laerdal Medical Corporation·February 18, 2026

    HEARTSINE SAMARITAN 300P AND PAK PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·May 6, 2014

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·October 13, 2010

    UNKNOWN DEPUY ASR HEAD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KXA·December 19, 2012

    Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.

    FDA Enforcement
    Class II ·Terminated·Laerdal Medical (Suzhou) Co., Ltd.·January 27, 2021

    Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;

    FDA Recall
    Open, Classified ·Laerdal Medical Corporation·Product code JCX·January 13, 2026

    Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.

    FDA Recall
    Terminated ·Laerdal Medical (Suzhou) Co., Ltd. Science & Technology Ind. Park No.·Product code JCX·December 18, 2020