Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-SOAK(TM) CONDITIONING SOLUTION WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID#84392

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALCON SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-FREE(R) SUPRACLENS(TM) DAILY PROTEIN REMOVER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALCON MULTI-PURPOSE SOLUTION ID 81573

EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6

FDA 510(k)

FDA Class 2 ·Dental

WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rugged Oxygen Generator (ROG) (RO01-00001)

FDA 510(k)

FDA Class 2 ·Anesthesiology

WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ATRICURE DISSECTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KidneyIntelX.dkd

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TSRH SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

NeoSpan Compression Staple Impant w/instruments

FDA 510(k)

FDA Class 2 ·Orthopedic

ERA 2000A

FDA 510(k)

FDA Class 2 ·Anesthesiology

PIVOX(tm) Oblique Lateral Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

HAND HELD MEDISPACER

FDA 510(k)

FDA Class 2 ·Anesthesiology

STAT GAS MODULE

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TENS device-EmeTerm, CinvStop

FDA 510(k)

FDA Class 2 ·Neurology

SPEED XL

FDA 510(k)

FDA Class 2 ·Orthopedic