Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·BOSTON EQUALENS(R) AND BOSTON RXD(R)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OCUSIL(TM) CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·RIGID GAS PERMEABLE CONTACT LENSES

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OPTACRYL K

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·O-PERM F60 RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OPTACRYL 60 - CLEAR

ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)

FDA 510(k)

FDA Class 2 ·Neurology

CMV MICROASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

APTT REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

COE PAK AUTO MIX, REGULAR OR HARD SET

FDA 510(k)

FDA Class 2 ·Dental

DATASCOPE ARTERIAL CANNULA W/ACCESS PORT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT

FDA 510(k)

FDA Class 2 ·Microbiology

PROTEIN S CONTROL PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SILK'N FX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

POREX(TM) PROSTHESIS, CHIN, INTERNAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery