CDI Blood Parameter Monitoring System 550

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Quantum Workstation

FDA 510(k)

FDA Class 2 ·Cardiovascular

URODYNAMIC ANALYSIS MODULE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Quantum Workstation 12 Elite

FDA 510(k)

FDA Class 2 ·Cardiovascular

LUMEN-4 URODYNAMIC CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STERIZO Total Hip System

FDA UDI

CPM MEDICAL CONSULTANTS, LLC·B565M221554281·Liner, Elevated Face Sz 54x28

STERIZO Total Hip System

FDA UDI

CPM MEDICAL CONSULTANTS, LLC·B565M220052361·Liner, Neutral Face Sz 52x36

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE and On-X Ascending Aortic Prothesis

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE AND ON-X ASCENDING AORTIC PROSTHESIS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·SODIUM HYALURONATE OPHTHALMIC VISCOELEASTIC DEVICES (OVD) HEALON, HEALON GV AND HEALON5

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (3% SODIUM HYALURONATE), MODEL VT585

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·ISPAN PERFLUOROPROPANE C3F8 GAS

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·ISPAN Perfluoropropane C3F8 Gas

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy