TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ZETAPLUS (PUTTY)

FDA 510(k)

FDA Class 2 ·Dental

VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

QUATROLOC FEMORAL COMPONENT & HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

STORZ DP4600 ANTERIOR INTRAOCULAR PRESSURE CONTROL PACK

FDA 510(k)

FDA Class 2 ·Ophthalmic

OPHTHASONIC A-SCAN

FDA 510(k)

FDA Class 2 ·Radiology

STORZ MVS 19 & 20 GAUGE SCLERAL PLUGS

FDA 510(k)

FDA Class 2 ·Ophthalmic

STORZ FIBEROPTIC ENDO-ILLUMINATORS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CERNER FETALINK+(VERSION1.0)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CALCIUM (ARSENAZO III) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE

FDA 510(k)

FDA Class 2 ·Ophthalmic

SafetyFix EasyOut System

FDA 510(k)

FDA Class 2 ·Orthopedic

STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISP. HYPERINFLATION BAG SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

Steerable catheter control system

FDA 510(k)

FDA Class 2 ·Cardiovascular

SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096

FDA 510(k)

FDA Class 2 ·Hematology

MONOCLONAL ANTIBODY ANTI-CD19

FDA 510(k)

FDA Class 2 ·Hematology

XOMED MICRO-IRRIGATOR

FDA 510(k)

FDA Class 2 ·General Hospital

THE SIGNATURE SERIES, IMC IV

FDA 510(k)

FDA Class 2 ·Physical Medicine