Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 411) AND PRECICONTROL ANTI-HCV

DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX

FDA 510(k)

FDA Class 2 ·Dental

TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALLERGAN(R) HYDROCARE(R) CLEAN & DISINFECT SOLUTIO

THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500

FDA 510(k)

FDA Class 2 ·Cardiovascular

MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

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)

Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SIGMA ELITE

FDA 510(k)

FDA Class 2 ·Anesthesiology

N LATEX STFR REAGENT

FDA 510(k)

FDA Class 2 ·Immunology

N PROTEIN STANDARD SL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N PROTEIN STANDARD UY CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry