BEUDAMED
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    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices

    A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.

    FDA Enforcement
    Class II ·Terminated·Alto Development Corp·August 7, 2019

    A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) 021-010 MYO/Wire Ultra-Flex Monopolar (Org.,2-0) 021-011 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0) Used as a connection between temporary cardiac pacing or monitoring equipment and the heart.

    FDA Recall
    Terminated ·Alto Development Corp·Product code LDF·June 21, 2019

    COMP TA1019M-1 DOME

    FDA UDI
    ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.·00886333622122·Critiflo Dome at 45 degree on a mounting plate

    MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG.

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG.

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE

    FDA Adverse Event
    Death ·AIZU OLYMPUS CO., LTD.·Product code FDA·January 2, 2024

    EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE

    FDA Adverse Event
    Injury ·AIZU OLYMPUS CO., LTD.·Product code FDA·January 2, 2024

    IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·April 2, 2026

    SINGLE USE ELECTROSURGICAL KNIFE

    FDA Adverse Event
    Injury ·AOMORI OLYMPUS CO., LTD.·Product code KNS·March 12, 2024

    CAROLINA LIQUID CHEMISTRIES CORP.® ISE CALIBRATOR 1 DT908

    FDA UDI
    CAROLINA LIQUID CHEMISTRIES CORPORATION·00817302024494·ISE CALIBRATOR 1

    Army Corp of Engineers EM385-1-1 - 36 Refill

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588189093·Army Corp of Engineers EM385-1-1 - 36 Refill

    HIGH FLOW INSUFFLATION UNIT

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code HIF·October 14, 2020

    24M - Army Corps of Engineers - EM 385-1-1 - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588169682·24M - Army Corps of Engineers - EM 385-1-1 - Metal

    ROSA Comp Mini Reamer - Step 1

    FDA UDI
    Zimmer, Inc.·00889024680869·

    DUODENOVIDEOSCOPE

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·July 27, 2021

    Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·February 19, 2014

    PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD

    FDA Adverse Event
    Death ·COVIDIEN·Product code FGE·June 24, 2016

    4K CAMERA HEAD

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FET·August 27, 2018

    24PW - Army Corps of Engineers - EM 385-1-1 - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588160696·24PW - Army Corps of Engineers - EM 385-1-1 - P...