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    Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic conventional and mammography images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LMC·May 16, 2008

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Recall
    Terminated ·Carl Zeiss Meditec AG Carl Zeiss Promenade 10 Jena Germany·Product code HJO·October 27, 2015

    Aquilion 64 CT System; Model number TSX-101 A/H The product is an x-ray device that uses digital geometry to generate a three-dimensional image of the inside of an object from a large series of two-dimensional X-ray images take around a single axis of rotation

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·January 8, 2009

    OPMI VARIO 700 Surgical Microscope. Manufactured by: Carl Zeiss Meditec AG, Oberkochen, Germany. Provide a magnified view of the surgical field.

    FDA Recall
    Terminated ·Carl Zeiss Meditec, Inc.·Product code EPT·September 26, 2011

    Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·January 24, 2023

    da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·February 10, 2023

    Focus DAILIES Toric (nelfilcon), One-Day Contact Lenses, Daily Disposable (hydrophilic) soft contact lens, Rx only, Sterile, -1.50, -1.75 x 090, BC 8.6, DIA 14.2, CIBA Vision Corp., Duluth, GA 30097. USA. The product is packaged and distributed as 15 and 30 packs.

    FDA Recall
    Terminated ·Ciba Vision Corporation·Product code LPL·May 6, 2003

    MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.

    FDA Recall
    Terminated ·Bausch & Lomb Surgical, Inc.·Product code MJP·November 7, 2020

    Sedecal NOVA FA DR System. for diagnostic radiography.

    FDA Recall
    Open, Classified ·Sedecal S.A. Pol. Industrial Rio De Janiero Calle Pelaya 9-13 Algete Spain·Product code MQB·July 18, 2018

    DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code HWC·May 12, 2017

    DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code HWC·May 12, 2017

    DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code HWC·May 12, 2017

    DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code HWC·May 12, 2017

    DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code HTO·November 19, 2020

    DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.031S

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code HTO·November 19, 2020

    DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code HTO·November 19, 2020

    DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code HTO·November 19, 2020

    DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code HTO·November 19, 2020

    DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code HTO·November 19, 2020

    DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.027S

    FDA Recall
    Terminated ·Synthes (USA) Products LLC·Product code HTO·November 19, 2020