MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS

FDA 510(k)

FDA Class 2 ·Neurology

AUTOCON II 200 ELECTROSURGICAL GENERATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

COULTER CLONE T1 MONOCLONAL ANTIBODY

FDA 510(k)

FDA Class 2 ·Hematology

ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR

FDA 510(k)

FDA Class 2 ·Radiology

ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OPERATING ROOM TOWELS -STERILE & NON-STERILE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

Aero Chrome* Select Breathable Performance Surgical Gowns

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ArtiSential Laparoscopic Instruments-Electrodes

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODEL 3200P/3200PR HYPERBARIC CHAMBER

FDA 510(k)

FDA Class 2 ·Anesthesiology

OMRON OSCILLOMETRIC DIGIT BLOOD PRES MONIT-HEM-706

FDA 510(k)

FDA Class 2 ·Cardiovascular

CharmFlex

FDA 510(k)

FDA Class 2 ·Dental

Tyvek(R) Roll with CI for STERLINKTM Sterilizer

FDA 510(k)

FDA Class 2 ·General Hospital

RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720

FDA 510(k)

FDA Class 2 ·Clinical Chemistry