BEUDAMED
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    LVivo Software Application

    FDA 510(k)
    FDA Class 2 ·Radiology

    VULCAN

    FDA UDI
    Smith & Nephew, Inc.·00885556539651·MTO KIT VULCAN GEN AUSTRALIA

    Vessel Probe 20cm 2.0mm, thin wire yellow alu handle

    FDA UDI
    Geister Medizintechnik GmbH·04057034045862·Vessel Probe 20cm 2.0mm, thin wire yellow...

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100530·Caddie, 7.5mm Screws

    Dilator, Vascular, acc. Geister 20cm 2.0mm alu-handle YELLOW

    FDA UDI
    Geister Medizintechnik GmbH·04057034045909·Dilator, Vascular, acc. Geister 20cm 2...

    Sapphire II Pro

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955942013·Balloon Dilatation Catheter

    FEP

    FDA UDI
    Merit Medical Systems, Inc.·00884450010761·

    CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HUMI-FLOW, MODEL 6-850-00/ 01/02

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·August 3, 2022

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·August 20, 2022

    KARDIAMOBILE

    FDA Adverse Event
    Malfunction ·ALIVECOR·Product code DPS·January 24, 2022

    PROXIMATE ILS CURVED CIR STAPL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·October 22, 2008

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 27, 2013

    MAXON

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GAM·August 3, 2011

    INDIGO SYSTEM SEPARATOR 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·September 13, 2022

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·October 13, 2023

    TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography The TVC Imaging System is an intravascular imaging device that simultaneously assesses vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid core-containing plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal views

    FDA Recall
    Terminated ·Infraredx, Inc.·Product code OGZ·December 15, 2016

    DigitalDiagnost C50 1.1

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·September 7, 2022

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014