BEUDAMED
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    Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Inc Mortara·April 28, 2021

    FC4000 MicroTargeting Electrode Kit 5x For use with Nexframe and Nexdrive Distributed by Medtronic Inc., Minneapolis, MN REF: FCH 4000 (5 Prefilled single use kits -5 packages and 2 electrodes each) Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.

    FDA Recall
    Terminated ·FHC, Inc.·Product code GZL·October 20, 2008

    QUIDEL Sofia SARS Antigen FIA IVD REF 20374

    FDA Enforcement
    Class II ·Terminated·Quidel Corporation·November 18, 2020

    Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.

    FDA Enforcement
    Class II ·Terminated·Quidel Corporation·February 20, 2013

    Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.

    FDA Enforcement
    Class II ·Terminated·Quidel Corporation·October 28, 2020

    CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024

    FDA Recall
    Terminated ·Neuro-Fitness LLC·Product code JXK·October 29, 2007

    Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures, for pre-implant and peri-implant surgery and for covering bone defects and empty sockets.

    FDA Recall
    Terminated ·Inion Ltd. Laakarinkatu 2 FIN-33520 Tampere Finland·Product code NPK·March 1, 2017

    Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code EIH·May 27, 2016

    Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code EIH·May 27, 2016

    Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.

    FDA Recall
    Terminated ·Custom Healthcare Systems, Inc.·Product code FCH·November 26, 2012

    Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.

    FDA Recall
    Terminated ·Custom Healthcare Systems, Inc.·Product code FCH·November 26, 2012

    Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelain

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code EIH·May 27, 2016

    Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code EIH·May 27, 2016

    Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code EIH·May 27, 2016

    Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code EIH·May 27, 2016

    Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code EIH·May 27, 2016

    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/CAM technology Product Number: 686193

    FDA Recall
    Terminated ·Ivoclar Vivadent AG Benderer Strasse 2 Schaan Liechtenstein·Product code EIH·April 13, 2020

    BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

    FDA Recall
    Terminated ·Prismatik Dentalcraft, Inc·Product code EIH·August 15, 2016

    Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code EIH·May 27, 2016

    Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code EIH·May 27, 2016