18 results
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47ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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C4 IMAGING LLC
FDA registration
C4 IMAGING LLC·3 products·🇺🇸 United States
Nova 5
FDA UDI
C4 IMAGING, LLC·00863593000242·The Fiducial Marker consists of a sealed polyet...
HDR MRI Lumen Marker
FDA UDI
C4 IMAGING, LLC·00863593000235·The HDR MRI Lumen Marker is a sealed high-densi...
Sirius MRI Marker
FDA UDI
C4 IMAGING, LLC·00863593000204·The SIRIUS MRI Marker is a component device ind...
Nova 10 Fiducial Marker
FDA UDI
C4 IMAGING, LLC·00863593000273·
Nova Z
FDA UDI
C4 IMAGING, LLC·00863593000297·Carton Containing up to 10 Fiducial Marker Load...
Nova Z
FDA UDI
C4 IMAGING, LLC·00863593000280·Fiducial marker loaded needle assembly
Nova 5
FDA UDI
C4 IMAGING, LLC·00863593000259·The Fiducial Marker consists of a sealed polyet...
Nova Z
FDA UDI
C4 IMAGING, LLC·00863593000266·Fiducial Marker
Sirius MRI Marker
FDA UDI
C4 IMAGING, LLC·00863593000211·The SIRIUS MRI Marker is a component device ind...
Sirius MRI Marker NS
FDA UDI
C4 IMAGING, LLC·00863593000228·The SIRIUS MRI Marker NS is a component device ...
NEXUS® BONESCALPEL® 10MM, BLUNT BLADE + IRRIGATION TUBING
FDA Adverse Event
Malfunction
·MISONIX, INC.·Product code LFL·March 14, 2025
TWIIST AUTOMATED INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·MILLYARD ADVANCED MEDICAL PRODUCTS, LLC·Product code QFG·April 3, 2026
HIRES¿ ULTRA 3D IMPLANT
FDA Adverse Event
Malfunction
·ADVANCED BIONICS, LLC·Product code MCM·January 4, 2024
HIRES 90K¿ IMPLANT
FDA Adverse Event
Malfunction
·ADVANCED BIONICS, LLC·Product code MCM·April 29, 2025
HIRES¿ ULTRA IMPLANT
FDA Adverse Event
Malfunction
·ADVANCED BIONICS, LLC·Product code MCM·September 27, 2024
HIRES¿ ULTRA IMPLANT
FDA Adverse Event
Malfunction
·ADVANCED BIONICS, LLC·Product code MCM·March 3, 2023
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