BEUDAMED
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    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    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

    Beckman Coulter Lipase, REF OSR6130 and OSR6230.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CDT·August 24, 2018

    Beckman Coulter Uric Acid, REF OSR6098, OSR6198, and OSR6698.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KNK·August 24, 2018

    MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.

    FDA Recall
    Terminated ·Nidek Inc·Product code HQF·June 9, 2014

    Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CHH·April 13, 2016

    Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KNK·April 13, 2016

    Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CDT·April 13, 2016

    Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CDT·April 13, 2016

    Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-Lactate in human plasma and cerebrospinal fluid (CSF) on Beckman Coulter AU analyzers.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KHP·April 13, 2016

    Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CHH·December 15, 2014

    Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.

    FDA Recall
    Terminated ·Nidek Inc·Product code LZS·February 1, 2017

    Beckman Coulter, Lactate Assay, Catalog No. OSR6X93

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KHP·December 15, 2014

    EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface.

    FDA Recall
    Terminated ·Nidek Inc·Product code LZS·March 24, 2015

    Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code KNK·December 15, 2014

    Beckman Coulter, Lipase Assay, Catalog No. OSR6X30

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CDT·December 15, 2014

    Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

    FDA Recall
    Terminated ·Nidek Inc·Product code GEX·March 25, 2015

    Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

    FDA Recall
    Terminated ·Nidek Inc·Product code GEX·March 25, 2015

    GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

    FDA Recall
    Terminated ·Nidek Inc·Product code GEX·May 16, 2014

    AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JGJ·December 8, 2021