35 results
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Sources: EU EUDAMED, US FDA
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Country: Australia
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Kico Knee Innovation Company Pty Ltd
Manufacturer
🇦🇺 Australia
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
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
EasyScreen™ Enteric PCR Positive Control
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Genetic Signatures Ltd·1 device
EasyScreen® Respiratory PCR Positive Control
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Genetic Signatures Ltd·1 device
EasyScreen® SARS CoV-2 Detection Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Genetic Signatures Ltd·1 device
EasyScreen™ Sample Processing Kit
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Genetic Signatures Ltd·3 devices
Step 2 Plates for Atypical Pneumonia 8-well
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·AusDiagnostics Pty Ltd·1 device
Step 2 Plates for Urinogenital (8-well)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·AusDiagnostics Pty Ltd·1 device
Step 2 Plates for Pneumonia (16-well)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·AusDiagnostics Pty Ltd·1 device
Step 2 Plates for Viral CSF (8-well)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·AusDiagnostics Pty Ltd·1 device
Step 2 Plates for Urinogenital and Resistance 12-well
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·AusDiagnostics Pty Ltd·1 device
Step 2 Plates for STI (16-well)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·AusDiagnostics Pty Ltd·1 device
Step 2 Plates for Herpes, Enterovirus and Adenovirus 8-well
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·AusDiagnostics Pty Ltd·1 device
Step 2 Plates for Viral Panel 12-well
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·AusDiagnostics Pty Ltd·1 device
Step 2 Plates for Urinogenital and Resistance 12 well
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·AusDiagnostics Pty Ltd·1 device
EasyScreen™ Pan-Enteric Pathogen Detection Kit (PE001)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Genetic Signatures Ltd·1 device
EasyScreen™ Pan-Enteric Pathogen Detection Kit (PE001)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Genetic Signatures Ltd·1 device
EasyScreen™ Pan-Enteric Pathogen Detection Kit (PE001)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Genetic Signatures Ltd·1 device