27 results
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18ms
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Sources: EU EUDAMED, US FDA
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Country: Australia
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Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-28050, Tracker E
FDA Enforcement
Class II
·Ongoing·Kico Knee Innovation Company·June 10, 2026
Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C
FDA Enforcement
Class II
·Ongoing·Kico Knee Innovation Company·June 10, 2026
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
FDA Enforcement
Class II
·Ongoing·Oxoid Australia Pty Limited·April 8, 2026
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: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The ARVIS" system is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components. Description: ARVIS Shoulder is a computer-controlled surgical navigation system for shoulder arthroplasty. It aids the surgeon in making intra-operative measurements and locating anatomical structures of the shoulder joint based on the patient s preoperative imaging to assist with selection and positioning of orthopedic implant components. The system consists of software, electronic hardware and surgical instruments. The device s workflow involves CT based preoperative planning followed by intraoperative navigation and execution. The preoperative planning software enables 3D virtual implant positioning based on the patient s CT reconstructed digital bone model and bony landmarks. The shoulder navigation application software then matches the patient s digital bone model and landmarks to the intraoperative landmarks registered by the surgeon, allowing an image-based navigation to follow. The surgeon uses the plan data as guidance to navigate and help position shoulder instruments and implants.
FDA Enforcement
Class II
·Ongoing·Kico Knee Innovation Company·October 22, 2025
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
Ellume COVID-19 Home Test
FDA Enforcement
Class I
·Ongoing·ELLUME LTD·November 17, 2021
AirFit N10 Nasal Masks and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
AirFit N20 Nasal Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
AirTouch N20 Nasal Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
AirFit F20 Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
Astral 100 and Astral 150 ventilators
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·November 1, 2023
SOZO Bilateral Arm L-Dex Software
FDA Enforcement
Class II
·Ongoing·Impedimed Limited·November 1, 2023