SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7

FDA 510(k)

FDA Class 2 ·Physical Medicine

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NIC 1800 NEEDLE DISPOSAL SYSTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALLERGAN(R) PRESERVED SALINE SOL.SPEC CHANGE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·WET-N-SOAK(TM) REWETTING DROPS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALLERGAN(R) REWETTING DROPS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LC-65 (R) DAILY CONTACT LENS CLEANER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·WET-N-SOAK

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ULTRA CARE (TM) NEUTRALIZING TABLET

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)

NAIMCO, INC., IONTOPHORESIS DRUG DELIVERY ELECTRODES, MODELS 201-400, 201-401, 201-402, 201-403 AND 201-405

FDA 510(k)

FDA Class 2 ·Physical Medicine

EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY THREADED FUSION CAGE(TFC)

Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws

FDA 510(k)

FDA Class 2 ·Orthopedic

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM

Bone Grafting Material, For Dental Bone Repair

FDA Pre-Market Approval

FDA Class 2 ·CERASORB DENTAL

Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates

FDA 510(k)

FDA Class 2 ·Orthopedic

HYGIENIC AIR PURIFYING DEVICE

FDA 510(k)

FDA Class 2 ·General Hospital

STERILE CORMED MEDIPORT

FDA 510(k)

FDA Class 2 ·General Hospital