DENTISEPTIC HPC

FDA 510(k)

FDA Class 1 ·Dental

HPC TM (HEPARINIZED PLASMA CONTROL)

FDA 510(k)

FDA Class 2 ·Hematology

ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRIAL LENS SET

FDA 510(k)

FDA Class 1 ·Ophthalmic

TRIA LENS SET

FDA 510(k)

FDA Class 1 ·Ophthalmic

LENS SET, MENTOR TRIAL

FDA 510(k)

FDA Class 1 ·Ophthalmic

BOBES LENS SET

FDA 510(k)

FDA Class 1 ·Ophthalmic

ACC CROSS CYLINDERS

FDA 510(k)

FDA Class 1 ·Ophthalmic

OPHTHALMIC TRIAL LENSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

MARCO TRIAL SETS

FDA 510(k)

FDA Class 1 ·Ophthalmic

OTI MODEL TLS-60

FDA 510(k)

FDA Class 1 ·Ophthalmic

WOODLYN FULL APERTURE TRIAL LENS SET

FDA 510(k)

FDA Class 1 ·Ophthalmic

CONTACT LENSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

WOODLYN CLASSIC TRIAL LENS SET

FDA 510(k)

FDA Class 1 ·Ophthalmic

BURTON TRIAL LENS SET

FDA 510(k)

FDA Class 1 ·Ophthalmic

CONFIRMATION TESTS

FDA 510(k)

FDA Class 1 ·Ophthalmic

ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA

FDA 510(k)

FDA Class 2 ·Cardiovascular

HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY

FDA 510(k)

FDA Class 2 ·Hematology

GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C

FDA 510(k)

FDA Class 2 ·General Hospital

IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT

FDA 510(k)

FDA Class 2 ·Immunology