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    The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous and choroid. The PLEX Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.

    FDA Recall
    Terminated ·Carl Zeiss Meditec, Inc.·Product code OBO·October 16, 2018

    Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher, with Normative Database, manufactured by Optovue, Fremont, CA The RTVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Recall
    Terminated ·Optovue Inc.·Product code OBO·January 8, 2010

    Widefield OCT software feature for the Spectralis HRA+OCT and variants

    FDA Recall
    Terminated ·Heidelberg Engineering·Product code OBO·December 8, 2017

    Cirrus HD-OCT Model 4000 instruments, new and refurbished, distributed with, or upgraded to, version v 1.0 - 4.5, 5.0.0 or 5.1.0 The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device.

    FDA Recall
    Terminated ·Carl Zeiss Meditec Inc·Product code OBO·March 10, 2011

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Recall
    Terminated ·Optovue Inc.·Product code OBO·September 7, 2012

    OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4

    FDA Recall
    Open, Classified ·Haag-Streit USA Inc·Product code OBO·November 3, 2021

    CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex

    FDA Recall
    Open, Classified ·Carl Zeiss Meditec, Inc.·Product code OBO·January 14, 2022

    SPECTRALIS with HEYEX2 image management system. a non-contact ophthalmic diagnostic imaging device.

    FDA Recall
    Terminated ·Heidelberg Engineering GmbH Tiergartenstr. 15 Heidelberg Germany·Product code OBO·July 3, 2019

    RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software)

    FDA Recall
    Terminated ·Optovue Inc.·Product code OBO·February 21, 2012

    Cirrus HD-OCT Model 400 instruments; new and refurbished, with or upgraded to, version 4.6 or 5.1.0 software. The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device.

    FDA Recall
    Terminated ·Carl Zeiss Meditec Inc·Product code OBO·March 10, 2011

    Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"

    FDA Recall
    Open, Classified ·Carl Zeiss Meditec, Inc.·Product code OBO·July 8, 2021

    ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·November 16, 2015

    ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M, PSCupA-10MO, PSCUp-10AB; ProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM; ProScreen 10 Panel Dip Card, Item No. PSD-10MMO-300, PSD-10MOX, PSD-10M, PSD-10CMO3, PSD-10APO-300; ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO-300; ProScreen 11 Panel Dip Card, Item No. PSD-11MT; ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU; ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M, PSCupA-12PP; ProScreen 12 Panel Dip Card, Item No. PSD-12BUP ProScreen 5 Panel Dip Card, Item No. PSD-5MB; ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB-300; ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU; ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU; ProScreen 6 Panel Dip Card, Item No. PSD-6MBO, PSD-6MTDBO-300, PSD-6MB, PSD-6BUPO; ProScreen 7 Panel Dip Card, Item No. PSD-7MO, PSD-7M; ProScreen 8 Panel Dip Card, Item No. PSD-8P; ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P; ProScreen 9 Panel Dip Card, Item No. PSD-9P; ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W; ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W; ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W; ProScreen Cup, Item No. PSCup-6MB-W, PSCupA-6MB-W, PSCup-6BO-W, PSCup-8P-W, PSCUp-10AB, PSCup-10MMO-300; ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W; These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Recall
    Terminated ·Ameditech Inc·Product code JXM·October 20, 2015

    Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from donor.

    FDA Recall
    Terminated ·Combat Medical Systems, LLC·Product code POQ·December 23, 2020

    LAPAROSCOPY ABO PACK (1) (2) CUSTOMED CONTENTS: (1) GOWN SURG. REINFORCED X-LARGE TOWEL I WRAP (2) TOWELS ABSORBENT 15" X 20" (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (4) DRAPE UTILITY WITH TAPE (1) SUTURE BAG FLORAL (1) DRAPE LAPAROSCOPY CHOLE W/TROU (1) TABLE COVER REINFORCED 50" X 90" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code FDE·May 20, 2014

    Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood convenience kit. The Fresh Whole Blood Transfusion Set contains everything needed to test for ABO/Rh compatibility and perform a fresh whole blood transfusion in a compact sealed package.

    FDA Recall
    Terminated ·Combat Medical Systems, LLC·Product code POQ·December 23, 2020

    IBO Blade, Right, for use with Stryker TPS Reciprocating Saw, REF 5100-37-901, Stryker Instruments, Kalamazoo, MI. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·October 18, 2011

    IBO Blade, Left, for use with Stryker TPS Reciprocating Saw, REF 5100-37-902, Stryker Instruments, Kalamazoo, MI. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·October 18, 2011

    Right IBO Blade , for use with Stryker TPS Reciprocating Saw, REF 5100-37-901S2, Stryker Instruments, Kalamazoo, MI. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·October 18, 2011

    Right/Left IBO Blade Set, for use with Stryker TPS Reciprocating Saw, REF 5100-37-903, Stryker Instruments, Kalamazoo, MI. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·October 18, 2011