MEDSAT OXYGEN SATURATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CDI(TM) 300, 400 & 100, MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPECTRUM M2 MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Quantum Workstation 12.1

FDA 510(k)

FDA Class 2 ·Cardiovascular

IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CDI Blood Parameter Monitoring System 550

FDA 510(k)

FDA Class 2 ·Cardiovascular

Quantum Workstation

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX TACROLIMUS II

Fluorescence Polarization Immunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·TDX/TDXFLX CYCLOSPORINE AND METABOLITES WHOLE BLOOD/MONOCLONAL WHOLE BLOOD

ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

FDA Pre-Market Approval

FDA Class 2 ·P.C.A.(TM) TOTAL KNEE SYSTEM

Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

FDA Pre-Market Approval

FDA Class 2 ·P.C.A.(TM) TOTAL KNEE SYSTEM

Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Monobond Etch & Prime

FDA 510(k)

FDA Class 2 ·Dental

B.Light Clear Evo and B.Light Restore Evo

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Tetric CAD

FDA 510(k)

FDA Class 2 ·Dental

CYTOPREP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology