BEUDAMED
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    PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES

    FDA 510(k)
    FDA Class 2 ·Hematology

    ERECTION INDUCER DEVICE (EID)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EID

    FDA Adverse Event
    Death ·WOLF TORY MED., INC.·Product code BTR·December 2, 1994

    ONCOR IMPRESSION PLUS

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code IYE·March 19, 2007

    ELECTRONIC INFUSION DEVICE

    FDA Adverse Event
    Injury ·UNKNOWN·Product code LZG·April 4, 1995

    FACTOR VIII RELATED ANTIGEN ROCKET EID

    FDA 510(k)
    FDA Class 2 ·Hematology

    BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357

    FDA 510(k)
    FDA Class 2 ·Hematology

    BIOPOOL PROTEIN C EID KIT AND BULK PLATES

    FDA 510(k)
    FDA Class 2 ·Hematology

    ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DTQ·April 17, 2018

    PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359

    FDA 510(k)
    FDA Class 2 ·Hematology

    ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DTQ·June 21, 2018

    HX2 TEMPERATURE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·February 23, 2012

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·July 3, 2024

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    FDA Adverse Event
    Injury ·BECTON, DICKINSON & CO., (BD)·Product code FMI·October 27, 2023

    REZUM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·June 18, 2024

    360 EXPRESS BALLOON

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code GEI·August 10, 2016

    ID CORE XT

    FDA Adverse Event
    Malfunction ·PROGENIKA BIOPHARMA, S.A·Product code PEP·March 12, 2021

    LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment

    FDA Enforcement
    Class II ·Terminated·LMA North America Inc·July 25, 2012