17 results
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25ms
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Sources: EU EUDAMED, US FDA
AESCULAP BONE MILL
FDA 510(k)
FDA Class 1
·Orthopedic
PREMIER® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00681490482073·SCREW 6860016 VAST CNCLLS 4.0X16MM
Trimline
FDA UDI
ORMCO CORPORATION·00889989051575·UPPER RIGHT SECOND MOLAR TRIMLINE BAND SIZE 16
LEONE SPA
FDA UDI
LEONE SPA·08033707031987·WEB 1ST MOLAR BANDS n.LR 16
NTI
FDA UDI
NTI - Kahla GmbH Rotary Dental Instruments·E310860016CFG1·NTI Diamond Coarse FG
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837016012·
Electroplated diamond RA 860 016
FDA UDI
Diaswiss SA·07630049992863·Dental diamond instrument for intraoral use
Steth IO
FDA 510(k)
FDA Class 2
·Cardiovascular
THROMCAT THROMBECTOMY CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
CURLIN ADMINISTRATION SET
FDA Adverse Event
Malfunction
·MOOG MED DEVICES GROUP·Product code FRN·October 31, 2012
EXCEL CONSOLE WITH FOOTSWITCH EACH1
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES (IRELAND) LTD.·Product code LFL·September 17, 2010
IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 14, 2016
IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 14, 2018
IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. The IQon Spectral CT system acquires one CT dataset composed of data from a higher-energy detected x-ray spectrum and a lower-energy detected x-ray spectrum. The two spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·January 18, 2017
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012