BEUDAMED
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    Datex-Ohmeda S/5 Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCM Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and neurophysiological status of all hospital patients.

    FDA Recall
    Terminated ·GE Medical Systems Information Tecnology 9900 Inovation Drive RP 2122 3rd Floor Wauwatosa WI 53226·Product code MLD·February 6, 2006

    Datex-Ohmeda S/5 Compact Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCCM Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and neurophysiological status of all hospital patients.

    FDA Recall
    Terminated ·GE Medical Systems Information Tecnology 9900 Inovation Drive RP 2122 3rd Floor Wauwatosa WI 53226·Product code MLD·February 6, 2006

    Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Ambler Surgical brand name.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HKY·September 8, 2014

    Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Versions: 11.6.0 and prior

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code HKI·December 9, 2016

    RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.

    FDA Recall
    Terminated ·Clarity Medical Systems Inc·Product code HKI·January 24, 2014

    Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Stations.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code HKI·December 9, 2016

    Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Millennium Surgical, Symmetry Surgical, Accutome, Boss Instruments, and Medline Industries brand names.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HKY·September 8, 2014

    Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.

    FDA Recall
    Terminated ·Clarity Medical Systems Inc·Product code HKI·March 7, 2014

    NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.

    FDA Recall
    Terminated ·Nidek Inc·Product code HKI·August 1, 2013

    The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System Product Usage: The WinStation Retinal Imager has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging) and anterior segement (slit lamp imaging), and fluorescein and ICG angiographic images in a non-invasive manner.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code HKI·December 20, 2018

    iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior. ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects.

    FDA Recall
    Terminated ·Optovue, Inc.·Product code HKI·July 27, 2017

    Retcam3 & Retcam Shuttle with version 6.0 software. Clarity Medical Systems, Inc. 5775 W. Las Positas Blvd, Suite 200 Pleasanton, CA 94588 General ophthalmic imaging including retinal, corneal and external imaging. Photodocumentation of pediatric ocular diseases including retinopathy or prematurity (ROP). Screening of Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.

    FDA Recall
    Terminated ·Clarity Medical Systems Inc·Product code HKI·February 2, 2012

    Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.

    FDA Recall
    Terminated ·Nidek Inc·Product code HKI·June 16, 2014

    Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expiration: July 14, 2009; Catalog Number: 4468.

    FDA Recall
    Terminated ·Cyberkinetics Neurotechnology Systems, Inc.·Product code GZL·February 4, 2009

    N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·March 1, 2017

    VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·June 26, 2013

    ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.

    FDA Enforcement
    Class I ·Terminated·Acist Medical Systems·March 10, 2021

    ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·July 9, 2014

    VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code LPS·April 1, 2013

    ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.

    FDA Recall
    Terminated ·Acist Medical Systems·Product code OBJ·January 22, 2021