BEUDAMED
    32 results · 11ms · Sources: EU EUDAMED, US FDA

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    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.

    FDA Enforcement
    Class II ·Terminated·Owen Mumford USA, Inc.·July 22, 2015

    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.

    FDA Recall
    Terminated ·Owen Mumford USA, Inc.·Product code FMF·December 11, 2014

    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

    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

    OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam.

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code EHJ·July 11, 2016

    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

    Zenostar MT Color C1 60ml, art. no. 681059. 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 Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686282EN

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

    Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks.

    FDA Recall
    Terminated ·Talladium Inc·Product code EIH·August 6, 2020

    Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain

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

    Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX, PO Box 250, 00031 Helsinki, Finland.

    FDA Recall
    Terminated ·Instrumentarium Dental, Inc.·Product code EDH·April 28, 2006

    Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain

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