System, Oxygen, Aqueous

FDA Pre-Market Approval

FDA Class 3 ·TherOx Downstream System

Pinehurst Anterior Cervical Plate System

FDA registration

SIGNATURE ORTHOPAEDICS PTY LIMITED·1 product·🇦🇺 Australia

Trial Devices

FDA registration

SIGNATURE ORTHOPAEDICS PTY LIMITED·1 product·🇦🇺 Australia

SIEMENS E.CAM

FDA registration

EvERX PTY LTD·2 products·🇦🇺 Australia

Munchies® VIBE

FDA registration

EOCA MD PTY LIMITED·1 product·🇦🇺 Australia

Biocomposite Screw

FDA registration

Signature Orthopaedics Europe Ltd·2 products·🇮🇪 Ireland

Olympus

FDA registration

MAKAR CONSULTING PTY LTD·3 products·🇦🇺 Australia

Patient Administration Set

FDA registration

CYCLOMEDICA AUSTRALIA PTY LTD·1 product·🇦🇺 Australia

AirSense 10

FDA registration

PPC MOULDING SERVICES PTY LTD·1 product·🇦🇺 Australia

DentaTRY

FDA registration

ASIGA·1 product·🇦🇺 Australia

Munchies

FDA registration

EOCA MD PTY LIMITED·1 product·🇦🇺 Australia

GE Venue Fit

FDA registration

MAKAR CONSULTING PTY LTD·3 products·🇦🇺 Australia

SignaSure Dual Mobility System

FDA registration

Signature Orthopaedics Europe Ltd·2 products·🇮🇪 Ireland

Pentax Gastroenterology

FDA registration

MAKAR CONSULTING PTY LTD·1 product·🇦🇺 Australia

Annalise Enterprise CXR

FDA registration

Annalise-AI India Pte Ltd·2 products·🇮🇳 India

Everglade Hip Stem

FDA registration

SIGNATURE ORTHOPAEDICS PTY LIMITED·2 products·🇦🇺 Australia

Dermatophytes and other Fungi 12-Well (REF 84115)

FDA registration

AUSDIAGNOSTICS·1 product·🇦🇺 Australia

AirPhysio Positive Expiratory Pressure (PEP) Device

FDA registration

Better Breathing Devices Pty Ltd·1 product·🇦🇺 Australia

SIEMENS ARCADIS VARIC

FDA registration

EvERX PTY LTD·2 products·🇦🇺 Australia

Siemens Somatom Definition Flash

FDA registration

EvERX PTY LTD·1 product·🇦🇺 Australia