257 results
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 m
FDA Recall
Open, Classified
·CORNEAT VISION, LTD. 4, Ha-Sheizaf Ra'Anana Israel·Product code QWU·August 18, 2025
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
FDA Recall
Open, Classified
·CORNEAT VISION, LTD. 4, Ha-Sheizaf Ra'Anana Israel·Product code QWU·October 16, 2024
EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202
FDA Recall
Open, Classified
·CORNEAT VISION, LTD. 4, Ha-Sheizaf Ra'Anana Israel·Product code QWU·August 18, 2025
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
Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery.
FDA Recall
Open, Classified
·Augmedics Ltd. 2 Ha-Otsma St Yokneam Illit Northern Israel·Product code OLO·April 14, 2025
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