Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·ATTUNETM Rotating Platform (RP) Total Knee System, ATTUNETM Cementless Rotating Platform (RP) Total Knee System, ATTUNET

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·AIA-PACK PA PSA, ST AIA-PACK PA PSA

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·METHAFILCON A SOFT HYDROPHILIC EXTENDED WEAR CONTACT LENSES

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·GEM21S Growth Factor Enhanced Matrix

VACUETTE SPEEDY QUICK-RELEASE HOLDER

FDA 510(k)

FDA Class 2 ·General Hospital

KROMALGIN IMPRESSION MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS

FDA 510(k)

FDA Class 2 ·General Hospital

NAMSA CHEMICAL PROCESS

FDA 510(k)

FDA Class 2 ·General Hospital

Talon DistalFix Humeral Nail

FDA 510(k)

FDA Class 2 ·Orthopedic

JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088

FDA 510(k)

FDA Class 2 ·Cardiovascular

PORT-O-SCOPE(TM)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NAMSA BIOLOGICAL INDICATOR SPORE STRIPS

FDA 510(k)

FDA Class 2 ·General Hospital

SPORTROL RAPID STERILITY INDICATOR

FDA 510(k)

FDA Class 2 ·General Hospital

SYSTEM U3 FOR GENTAMICIN

FDA 510(k)

FDA Class 2 ·Microbiology

VACUETTE SAFETY BLOOD COLLECTION SET

FDA 510(k)

FDA Class 2 ·General Hospital

VACUETTE EDTA K2 TUBES

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VACUETTE EDTA K2 GEL TUBES

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AMOXICILLIN/CLAVULANIC ACID 2/1

FDA 510(k)

FDA Class 2 ·Microbiology

D.L. SCOPE OPHTHALMOSCOPE

FDA 510(k)

FDA Class 2 ·Ophthalmic