13 results
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42ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·April 29, 2026
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·April 30, 2025
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·April 23, 2025
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·April 30, 2025
Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·April 23, 2025
MICRO-X Rover Mobile X-ray System, # MXU-RV19
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·December 18, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·December 18, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV35
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·December 18, 2024
MICRO-X Rover Mobile X-ray System, # MXU-RV35
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·December 4, 2024
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·October 5, 2022
Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouch level) - BF40181(Case box level) BF40182 (Carton box level) - BF40183(Over shipper level), STERILE
FDA Enforcement
Class II
·Terminated·Micro-Tech (Nanjing) Co., Ltd.·October 31, 2018
Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
FDA Enforcement
Class II
·Terminated·Micro-Tech (Nanjing) Co., Ltd.·May 23, 2018
Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
FDA Enforcement
Class II
·Terminated·Micro-Tech (Nanjing) Co., Ltd.·May 23, 2018