BEUDAMED
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    Filters FDA Recall × Status: Terminated × Clear all

    Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics·Product code MEH·December 2, 2002

    Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA

    FDA Recall
    Terminated ·Omnilife Science Inc.·Product code LZO·May 9, 2014

    IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St. Modiin, Israel 71700, Distributed by: Exalenz Bioscience Inc., 1313 N. Market St., Sute 5100, Wilmington, DE 19808 USA Product Usage: The IDkit:HP Two Test System is intended for use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. Urea Breath Tests are well established as reliable, non-invasive methods for detecting H. pylori. They are highly endorsed by various medical societies as the test of choice for initial detection as well as for post-treatment testing.

    FDA Recall
    Terminated ·Exalenz Bioscience Ltd Hamaayan 4 Modiin Israel·Product code MSQ·June 7, 2011

    Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only

    FDA Recall
    Terminated ·WEST PHARMA. SERVICES IL, LTD 4, Ha-Sheizaf Ra'Anana Israel·Product code LHI·December 26, 2018

    Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

    FDA Recall
    Terminated ·Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel·Product code NDP·July 26, 2021

    Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

    FDA Recall
    Terminated ·Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel·Product code DZE·May 30, 2019

    Scan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

    FDA Recall
    Terminated ·Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel·Product code NDP·July 26, 2021

    Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only

    FDA Recall
    Terminated ·WEST PHARMA. SERVICES IL, LTD 4, Ha-Sheizaf Ra'Anana Israel·Product code LHI·December 26, 2018

    Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only

    FDA Recall
    Terminated ·WEST PHARMA. SERVICES IL, LTD 4, Ha-Sheizaf Ra'Anana Israel·Product code LHI·December 26, 2018

    Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020

    FDA Recall
    Terminated ·Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel·Product code DZE·November 18, 2019

    Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

    FDA Recall
    Terminated ·Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel·Product code NDP·July 26, 2021

    Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

    FDA Recall
    Terminated ·Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel·Product code NDP·July 26, 2021

    Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

    FDA Recall
    Terminated ·Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel·Product code NDP·July 26, 2021

    Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

    FDA Recall
    Terminated ·Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel·Product code NDP·July 26, 2021

    Biomet 3i, Certain PreFormance Temporary Cylinder, Catalog Number: IPFTC42, Dental Implant, Biomet 3i, Palm Beach Gardens, FL 33410

    FDA Recall
    Terminated ·Product code NHA·October 8, 2007

    Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.

    FDA Recall
    Terminated ·Keystone Dental Inc·Product code NHA·July 5, 2011

    BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·June 25, 2014

    Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing without prescription***Consult instructions for use*** Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast.

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·May 31, 2012

    Certain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015

    Certain Gingihue 15 degree Pre- Angled Post Dental implants

    FDA Recall
    Terminated ·Biomet 3i, LLC·Product code NHA·November 25, 2015