4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SENSIBEAD EIA DIGOXIN KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CLIRANS E-SERIES HOLLOW FIBER DIALYZERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BD GENEOHM VANR ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

HASELMEIER PEN

FDA 510(k)

FDA Class 2 ·General Hospital

NEER-III OSTEOARTHRITIS GLENOID RESURFACE PROSTHE.

FDA 510(k)

FDA Class 2 ·Orthopedic

SAPPHIRE INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

CAPIOX III CARDIOPULMONARY BYPASS OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD DIRECTIGEN FLU A+B

FDA 510(k)

FDA Class 2 ·Microbiology

TRIO 300

FDA 510(k)

FDA Class 2 ·Physical Medicine

SILIMED NASAL L SHAPED IMPLANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN), CEFOTAXIME (GN), 0.5-64 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

DOHLMAN DOANE KERATOPROTHESIS

FDA 510(k)

FDA Class 2 ·Ophthalmic

TERUMO SENSIBEAD EIG HCG KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

Burn Resuscitation Decision Support System - Clinical (BRDSS-C)

FDA 510(k)

FDA Class 2 ·Anesthesiology

MAPS 10000

FDA 510(k)

FDA Class 2 ·Radiology

FROG (Filter Removal of Glass)

FDA 510(k)

FDA Class 2 ·General Hospital

BD Phoenix™ Automated Microbiology System

FDA 510(k)

FDA Class 2 ·Microbiology

MTF ALLOGRAFT ANCHOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery