BEUDAMED
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    Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle: Richard-Allan Scientific CYTO-STAIN G; REF 7501G; 1 Gallon/3.8L; Thermo Scientific.

    FDA Recall
    Terminated ·Richard-Allan Scientific Company·Product code HZJ·February 19, 2015

    Papanicolaou Stain EA-50. Product size configurations: 1L, 4L, and 10L. Item Nos. 7062X/75, 7062X/85, and 7062X/86.

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code HZJ·December 13, 2002

    Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz

    FDA Enforcement
    Class II ·Terminated·LivaNova USA·May 30, 2018

    Varian Medical Systems FastPlan, versions 5.5 and 5.5.1, model number HZ3, manufactured by Varian Medical Systems, Palo Alto, CA The product is a radiation treatment planning system.

    FDA Recall
    Terminated ·Varian Medical Systems Oncology Systems·Product code IYE·May 29, 2008

    ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system. Siemens Medical Solutions USA, Inc., Mountain View, CA

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYN·September 25, 2007

    FastPlan Treatment Planning System, Model HZ3, Varian Medical Systems, Palo Alto, CA. Varian FastPlan Treatment Planning System is a radiation treatment planning system composed of a high resolution UNIX graphics computer, a printer, a digitizing tablet, and radiation treatment planning application software.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·January 30, 2012

    Varian Medical Systems FastPlan software, Versions 5.5 and 5.5.1, Model Number HZ3, manufactured by Varian Medical Systems, Palo Alto, CA Treatment Planning System is intended as aid in quickly and precisely planning the radiation treatment of small cranial lesions such as an asteriovenous malformations, pituitar tumors, pincalomas, acoustic neuromas and malignant neoplasms.

    FDA Recall
    Terminated ·Varian Medical Systems Oncology Systems·Product code IYE·March 23, 2010

    Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03976; Model Number: HZ1; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·March 3, 2011

    Thermoplastic templates, single tooth Catalog Number: 040.526

    FDA Recall
    Terminated ·Straumann Manufacturing Inc.·Product code DZJ·January 30, 2006

    Stryker brand Consolidated Operating Room Equipment (CORE) System Powered Instrument Driver, REF 5400-50; Model 5400-050-000.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·August 5, 2005

    Stryker brand Consolidated Operating Room Equipment (CORE) SystemPowered Instrument Driver, REF 5400-50; Model 5400-050-000A.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·August 5, 2005

    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

    Thermoplastic templates, free-end situation Catalog Number: 040.527

    FDA Recall
    Terminated ·Straumann Manufacturing Inc.·Product code DZJ·January 30, 2006

    Left IBO Blade , for use with Stryker TPS or Core Reciprocating Saw, REF 5100-37-902S2, 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

    Avazzia Med-Best Therapeutic Massager; Model: BEST AV-1; P/N #MB04182-103; manufactured by Avazzia, Inc., Dallas, TX 75240.

    FDA Recall
    Terminated ·Avazzia, Inc·Product code GZJ·June 29, 2007

    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

    REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the device to use by or on the order of a physician Driver, Wire and Bone Drill; The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental, orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·October 2, 2013

    Avazzia BEST-RSI; Model: BEST AV-1; P/N #RS04303-103; manufactured by Avazzia, Inc., Dallas, TX 75240.

    FDA Recall
    Terminated ·Avazzia, Inc·Product code GZJ·June 29, 2007

    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