AIA-PACK CA 19-9

FDA 510(k)

FDA Class 2 ·Immunology

ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NCONTACT COAGULATION SYSTEM KIT, MODEL CSK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDTRONIC(R) MILLENIA (TM) FAMILY OF CORONARY BALLOON DILATATION CATHETERS

OMNIgene GUT Dx

FDA 510(k)

FDA Class 2 ·Microbiology

Gili Pro BioSensor (also known as “Gili BioSensor System”)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Visby Medical Women's Sexual Health Test

FDA 510(k)

FDA Class 2 ·Microbiology

DEKA ARM SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PYROGEN TESTING OF ACS/CORNARY DILATATION CATHETERS E-BEAM- RADIATION STERILIZER

ActiPatch

FDA 510(k)

FDA Class 2 ·Physical Medicine

Colibrí

FDA 510(k)

FDA Class 2 ·Microbiology

ActiPatch(R)

FDA 510(k)

FDA Class 2 ·Physical Medicine

BD Kiestra IdentifA

FDA 510(k)

FDA Class 2 ·Microbiology

BD Kiestra IdentifA

FDA 510(k)

FDA Class 2 ·Microbiology

Colibri System

FDA 510(k)

FDA Class 2 ·Microbiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·LYNX CONTOUR CORONARY BALLOON DILATATION CATHETER(A NEW MODEL OF THE FACT CATHETER).

cobas HCV

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima HCV Quant Dx Assay

FDA 510(k)

FDA Class 2 ·Microbiology

FibriCheck

FDA 510(k)

FDA Class 2 ·Cardiovascular

Oxehealth Vital Signs

FDA 510(k)

FDA Class 2 ·Cardiovascular