12 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
FDA Enforcement
Class II
·Terminated·Arrow International Inc·October 7, 2015
MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
FDA Recall
Terminated
·Astora·Product code PAH·October 26, 2015
The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing, minimize exam set-up time and allow routine diagnostic exams to be performed extraorally for improved clinical efficiency and patient experience. - Progeny Clarity Enhanced Filter Set provides superior diagnostic imaging quality - Exclusive Focal Trough Alignment reminder assists in consistent patient positioning - Progeny Imaging software included for download on an unlimited number of operatory workstations with no additional costs - Exclusive VantageTrust remote support and training service offered at no charge for the first 60 days of use - Ceph upgradeable for expanded extraoral exam capabilities - The Progeny Vantage Panoramic System s proudly designed and manufactured in the USA; 2013 Midmark Corporation; 675 Heathrow Drive Lincolnshire, IL 60069; 847-415-9800 Toll-free 888-924-3800
FDA Recall
Terminated
·Midmark Corp dba Progeny Inc·Product code MUH·September 20, 2013
SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.
FDA Recall
Terminated
·Aesthetics Biomedical, Inc.·Product code OUH·March 13, 2020
CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmented tomographic digital panoramic X-ray images to be used at the direction of healthcare professionals of the dento-maxillo-facial region of the human anatomy as diagnostic support for pediatric and adult patient.
FDA Recall
Terminated
·Carestream Health, Inc.·Product code MUH·January 8, 2015
Villa Sistemi Rotograph EVO 3D X-ray
FDA Recall
Terminated
·Villa Radiology Systems LLC·Product code MUH·August 5, 2015
Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage Panoramic X-Ray System is a class II extra oral X-Ray system used to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw and oral structures. When the system is equipped with the cephalometric option, the system will also provide cephalometric radiographic examinations for use in orthodontic treatment planning and evalu
FDA Recall
Terminated
·Midmark Corp dba Progeny Inc·Product code MUH·September 4, 2014
DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral Sensor is a USB-driven sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS / KaVo sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.
FDA Recall
Terminated
·KaVo Dental Technologies LLC·Product code MUH·April 29, 2019
Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation.
FDA Recall
Terminated
·Imaging Sciences International, LLC·Product code MUH·January 8, 2009
CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented tomographic digital panoramic X-ray images and three-dimensional digital X-ray images of the dentomaxillo-facial area to be used at the direction of healthcare professionals as diagnostic support for pediatric and adult patient.
FDA Recall
Terminated
·Carestream Health, Inc.·Product code MUH·January 8, 2015
i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as KaVo 3D eXam
FDA Recall
Terminated
·Imaging Sciences Intl Inc·Product code MUH·March 19, 2008
Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Gendex Dental Systems, 901 West Oakton Street, Des Plaines, IL 60018. Intended for use of the software is to control capture, display, treatments, analysis and saving of x-ray digital images.
FDA Recall
Terminated
·Gendex Dental Systems·Product code MUH·March 6, 2009