30 results
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21ms
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Sources: EU EUDAMED, US FDA
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Country: Australia
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OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
FDA Enforcement
Class II
·Ongoing·Oxoid Australia Pty Limited·April 8, 2026
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
Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
FDA Enforcement
Class II
·Terminated·Signature Orthopedics Pty Limited·February 20, 2019
Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
FDA Enforcement
Class II
·Terminated·Signature Orthopedics Pty Limited·February 20, 2019
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
Cocoon Convective Warming System, Product Code: CWS5000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.
FDA Enforcement
Class II
·Terminated·Signature Orthopedics Pty Limited·June 9, 2021
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
FDA Enforcement
Class II
·Ongoing·Ellex Medical Pty Ltd.·July 5, 2023
Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory components (Disposable EEG Wires, WaterTabs, WaterTabs Application Kit, and Take-home Kit).
FDA Enforcement
Class II
·Ongoing·SEER MEDICAL PTY LTD·September 25, 2024
HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.
FDA Enforcement
Class II
·Ongoing·Leica Biosystems Melbourne Pty Ltd·May 7, 2025
546003 MR5
Certificate
MDD Annex V·Livac Pty Ltd·DQS Medizinprodukte GmbH·2 Basic UDI-DIs
V1 003496 007
Certificate
IVDD Annex IV (excluding sections 4, 6)·AusDiagnostics Pty Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
V1 003469 0007
Certificate
IVDD Annex IV (excluding sections 4, 6)·AusDiagnostics Pty Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
170775883
Certificate
MDD Annex II (excluding section 4)·Navbit Pty Ltd·DQS Medizinprodukte GmbH·1 Basic UDI-DI
541616 MR2
Certificate
MDD Annex II (excluding section 4)·Navbit Pty Ltd·DQS Medizinprodukte GmbH·1 Basic UDI-DI
G2S 105080 0003
Certificate
MDD Annex V·Qlicksmart Pty Ltd·TÜV SÜD Product Service GmbH·3 Basic UDI-DIs
V1 003496 0007
Certificate
IVDD Annex IV (excluding sections 4, 6)·AusDiagnostics Pty Ltd·TÜV SÜD Product Service GmbH·24 Basic UDI-DIs
G1 096382 0009
Certificate
MDD Annex II (excluding section 4)·Ozdent Pty Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
V1 0034960007
Certificate
IVDD Annex IV (excluding sections 4, 6)·AusDiagnostics Pty Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI
CE 651490
Certificate
MDD Annex II (excluding section 4)·Micropace Pty Ltd·BSI Group The Netherlands B.V.·1 Basic UDI-DI