Endotoxin Activity Assay (EAA)

FDA 510(k)

FDA Class 2 ·Microbiology

SPECTRAL WEST NILE VIRUS IGM STATUS TEST

FDA 510(k)

FDA Class 2 ·Microbiology

ProCell Surgical Sponge-Blood Recovery Unit

FDA 510(k)

FDA Class 2 ·Anesthesiology

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE

SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SORIN C5 SYSTEM MODEL 58-00-00

FDA 510(k)

FDA Class 2 ·Cardiovascular

FilmArray Pneumonia Panel plus

FDA 510(k)

FDA Class 2 ·Pathology

BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)

FDA 510(k)

FDA Class 2 ·Pathology

FilmArray Pneumonia Panel plus

FDA 510(k)

FDA Class 2 ·Pathology

BI-FLEX URETERAL ACCESS SHEATH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

JFil Ureteral Stents, JFil Ureteral Stents ECO KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDOFLOW II - Irrigation, Warming and Suction System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RocaJJ Soft Stents

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ROCAMED ROCAUS PLATINUM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RocaTub Ureteral Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Bi-Flex Evo

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys FT4 III

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COBAS(R) CORE FT4 EIA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry