17 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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Step 1 tubes for CRE 16-well
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·AusDiagnostics Pty Ltd·1 device
Step 2 Plates for CRE 16-well
Basic UDI-DI
EU IVDD
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Eu Ivd General
·AusDiagnostics Pty Ltd·1 device
Step 1 tubes for CRE Reference 24-well
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·AusDiagnostics Pty Ltd·1 device
Step 2 Plates for CRE Reference 24-well
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·AusDiagnostics Pty Ltd·1 device
Step 1 tubes for CRE EU 16-well
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·AusDiagnostics Pty Ltd·1 device
Step 2 Plates for CRE EU 16-well
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·AusDiagnostics Pty Ltd·1 device
Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logical Acetabular Cups. Product Usage: Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: ¿ Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis ¿ Inflammatory joint disease including rheumatoid arthritis ¿ Correction of functional deformity including congenital hip dysplasia ¿ Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture ¿ Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement
FDA Enforcement
Class II
·Terminated·Signature Orthopedics Pty Limited·March 14, 2018
MICRO-X Rover Mobile X-ray System, # MXU-RV35
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·December 18, 2024
ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
FDA Enforcement
Class I
·Completed·ResMed Ltd.·February 12, 2020
AirTouch N20 Nasal Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
AirFit F30 Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
AirTouch F20 Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
AirFit F30i Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
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
Astral 100 and Astral 150 ventilators
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·November 1, 2023
AirFit F20 Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023