BEUDAMED
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    HIPPURATE DISK

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Precept

    FDA UDI
    Nuvasive, Inc.·00887517352576·PRECEPT Base, Instrument 1

    TLX

    FDA UDI
    Nuvasive, Inc.·00887517729552·TLX Implant, 10x11x31mm 15°

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5828013050·INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

    Curette

    FDA UDI
    KATENA PRODUCTS, INC.·00841668117798·Hardten DSEK Polisher

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    FDA Adverse Event
    Malfunction ·AMERICAN OPTISURGICAL, INC.·Product code LFL·February 24, 2014

    MERCI RETRIEVER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    FDA Adverse Event
    Malfunction ·AMERICAN OPTISURGICAL, INC.·Product code LFL·January 27, 2014

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    FDA Adverse Event
    Malfunction ·AMERICAN OPTISURGICAL, INC.·Product code LFL·January 27, 2014

    ELLIPSE DR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·May 8, 2014

    PLUM A+ UK WITH 3PIN

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 17, 2012

    PRECISION XTRA /OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·September 21, 2007

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Injury ·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012

    Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

    FDA Recall
    Terminated ·Micro Therapeutics Inc, Dba Ev3 Neurovascular·Product code KRA·September 23, 2011

    UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

    FDA Recall
    Terminated ·Micro Therapeutics Inc, Dba Ev3 Neurovascular·Product code KRA·September 23, 2011

    Axium Detachable Coil System Model Number: QC-2-2-3D. The AXIUM DETACHABLE COIL SYSTEM consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held I.D. (instant detacher) which when activated detached the coil from the delivery pusher tip. Some of the AX IUM Detachable coils are enlaced with PGLA microfilaments or Nylon microfilaments. I.D. (instant detached) is sold separately.

    FDA Recall
    Terminated ·Micro Therapeutics Inc, dba ev3 Neurovascular·Product code HCG·November 12, 2008

    TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.

    FDA Enforcement
    Class II ·Terminated·Tenex Health Inc·May 14, 2014

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022