21 results
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27ms
·
Sources: EU EUDAMED, US FDA
FUKUDA DENSHI CARDIMAX FCP-211
FDA 510(k)
FDA Class 2
·Cardiovascular
Trimline
FDA UDI
ORMCO CORPORATION·00889989051650·UPPER RIGHT SECOND MOLAR TRIMLINE BAND SIZE 24
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88600241·Max. 2. Molar band W-Fit left 24
LEONE SPA
FDA UDI
LEONE SPA·08033707032069·WEB 1ST MOLAR BANDS n.LR 24
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690120926·A/P FEMORAL CUTTING BLOCK SZ 4
Sternum Retractor
FDA UDI
KOROS U.S.A., INC.·10840199536150·Fraser Bailey Stermum Spreader 6" Arm, 24mm Bla...
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88600240101·Max. 2. Molar band W-Fit left 24
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88600240501·Max. 2. Molar band W-Fit left 24
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR88600240051·Max. 2. Molar band W-Fit left 24
ULTRAZYME ALKALINE PHOSPHATASE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
I.V. TAPE DOWN HOLDER
FDA 510(k)
FDA Class 1
·General Hospital
SENSIA SR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 10, 2014
CURLIN INFUSION 6000 PAINSMART IOD IV PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·October 31, 2012
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·June 22, 2015
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
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·October 1, 2025
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
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021