Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·RESOLVE/GP(TM) DAILY CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS-WET(TM)

AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)

FDA 510(k)

FDA Class 2 ·Ophthalmic

CEPHX- Cephalometric Analysis Software

FDA 510(k)

FDA Class 2 ·Radiology

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·DISINTEGRATOR PRO NEEDLE DESTRUCTION DEVICE

Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869

FDA 510(k)

FDA Class 2 ·General Hospital

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOF!PRO-CLEAN CONTACT LENS CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOF!PRO-CLEAN CONTACT LENS CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOF!PRO-CLEAN CONTACT LENS CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOF PRO-CLEAN CONTACT LENS CLEANER

Enzyme Immunoassay, Tracrolimus

FDA Pre-Market Approval

FDA Class 2 ·PRO-TRAC II TACROLIMUS ELISA KIT

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOF PRO-CLEAN CONTACT LENS CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOF PRO-CLEAN CONTACT LENS CLEANER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R)SOLITAIRE(TM) BALL.DIL.CATH.W/PRO/PEL(TM)

Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

FDA Pre-Market Approval

FDA Class 2 ·PRO OSTEON IMPLANT 500 HYDROXYAPATITE BONE VOID FILLER

BOBCAT DX

FDA 510(k)

FDA Class 2 ·Physical Medicine

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) SILK(TM)/AGIL(TM) BALL.DIL.CATH. W/PRO/PEL

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) SILK(TM)/AGIL(TM) BALL.DIL.CATH. W/PRO/PEL

N LATEX STFR REAGENT

FDA 510(k)

FDA Class 2 ·Immunology