12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Country: Canada
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CAREVENT ATV+ AND CAREVENT MRI
FDA 510(k)
FDA Class 2
·Anesthesiology
SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23
FDA 510(k)
FDA Class 2
·Radiology
VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51
FDA 510(k)
FDA Class 2
·Radiology
VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems.
FDA Enforcement
Class II
·Terminated·Innovative Magnetic Resonance Imaging Systems Inc.·November 28, 2012
IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.
FDA Enforcement
Class II
·Terminated·Intelerad Medical Systems·August 27, 2014
PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
FDA Enforcement
Class II
·Terminated·Zimmer CAS·December 10, 2014
Sanotize Research and Development Corp.
Manufacturer
🇨🇦 Canada
Freedom Concepts Inc.
Manufacturer
🇨🇦 Canada
PRIMED Medical Products Inc.
Manufacturer
🇨🇦 Canada
MPowrx Health and Wellness Products 2012 Inc.
Manufacturer
🇨🇦 Canada