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Sources: EU EUDAMED, US FDA
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Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
FDA Recall
Terminated
·FSC Laboratories, Inc·Product code NVP·May 16, 2016
Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.
FDA Enforcement
Class II
·Terminated·Agfa Healthcare NV·October 17, 2018
Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.
FDA Recall
Terminated
·Agfa Healthcare NV Septestraat 27 Mortsel Belgium·Product code LLZ·August 3, 2018
The Maestor System 225-312, Profile Abutment for Cement, 5mm
FDA Recall
Terminated
·BioHorizons Implant Systems Inc One Perimeter Park South·Product code NDP·June 3, 2005
Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve 4.8 mm is used to transfer the implant from the packaging to the patient via a plug-in connection and screwed in manually or mechanically.
FDA Recall
Terminated
·Thommen Medical AG Eschenweg 3 Bettlach Switzerland·Product code NDP·April 3, 2019
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
Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.
FDA Recall
Terminated
·Zimmer Dental Inc·Product code NDP·October 11, 2017
Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code NDP·March 14, 2019
Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code NDP·March 14, 2019
Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
FDA Recall
Terminated
·Straumann USA LLC·Product code NDP·May 27, 2021
Straumann Dental Implant System, SP Profile Drill, Short, 04.2 mm, RN, L25.0 mm, Stainless steel Ref. Number: 044.084
FDA Recall
Terminated
·The Straumann Company·Product code NDP·November 11, 2004
The Maestro System 204-503, Straight Permucosal Ext, 5mm x 3mm
FDA Recall
Terminated
·BioHorizons Implant Systems Inc One Perimeter Park South·Product code NDP·June 3, 2005
Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
FDA Recall
Terminated
·Zimmer Dental Inc·Product code NDP·July 10, 2017
Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
FDA Recall
Terminated
·Nobel Biocare Usa Llc·Product code NDP·March 14, 2019
Straumann Impression set for WN solid abutment H 4.00mm POM/ AI. Ref : 040.380 Kit Y4021. Intended to aid in the fabrication of dental prosthetics, and be used as a accessory with endosseous dental implants.
FDA Recall
Terminated
·Straumann Manufacturing Inc.·Product code NDP·June 15, 2010
Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number: 043.652S. Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.
FDA Recall
Terminated
·Straumann USA, LLC·Product code NDP·March 12, 2012
GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical Kit, Complete, Catalog TSVKIT. Used as a manual delivery tool that engages the Fixture Mount Transfer (FMT) to transport the dental implant from the product packaging to the osteotomy.
FDA Recall
Terminated
·Zimmer Dental Inc·Product code NDP·January 22, 2015
BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NDP·September 21, 2015
Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal. For dental and restorative procedures.
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NDP·August 10, 2015
IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A; IMPRESSION CAP CONT 4.5MM, REF ZOCIMP4S; IMPRESSION CAP,CONT,5.5MM, ANG, REF ZOCIMP5A; IMPRESSION CAP, CONT, 5.5MM, REF ZOCIMP5S; MPRESSION CAP, CONT, 6.5MM,ANG, REF ZOCIMP6A; IMPRESSION CAP, CONT, 6.5MM, REF ZOCIMP6S
FDA Recall
Terminated
·Zimmer Dental Inc·Product code NDP·July 10, 2017