19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Country: Australia
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CliniCloud Non-contact Thermometer, Model SPL1024
FDA 510(k)
FDA Class 2
·General Hospital
BladeSINGLE Non Sterile Blade Remover
Device
EU MDR
·
Eu Md Class 1
·Qlicksmart Pty Ltd·On the market·32 countries
Novoglan Non Surgical Phimosis Treatment
Device
EU MDR
·
Eu Md Class 1
·Platigo Solutions Pty Limited·On the market·7 countries
NON–IMPLANTABLE CARDIAC STIMULATORS – OTHER
Device
EU MDD
·
Eu Md Class 2b
·Micropace Pty Ltd·On the market·32 countries
BladeCASSETTE Non sterile Scalpel Blade Remover
Device
EU MDR
·
Eu Md Class 1
·Qlicksmart Pty Ltd·On the market·32 countries
Non–Invasive Blood Pressure Monitoring Instruments
Device
EU MDD
·
Eu Md Class 2a
·AtCor Medical Pty Ltd·On the market·22 countries
Non–Invasive Blood Pressure Monitoring Instruments
Device
EU MDD
·
Eu Md Class 2a
·AtCor Medical Pty Ltd·On the market·3 countries
BladeNeedleSYSTEM Non sterile Single Use Blade Remover
Device
EU MDR
·
Eu Md Class 1
·Qlicksmart Pty Ltd·On the market·32 countries
Qlicksmart Single Use Scalpel Blade Removers Non-Sterile
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·Qlicksmart Pty Ltd·3 devices
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
AirFit F20 Full Face Mask and User Guide
FDA Enforcement
Class I
·Ongoing·ResMed Ltd.·December 27, 2023
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
BLUBLOX PTY LTD (TA BON CHARGE)
FDA registration
BLUBLOX PTY LTD (TA BON CHARGE)·2 products·🇦🇺 Australia