Asept Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

primeMidline Catheters

FDA 510(k)

FDA Class 2 ·General Hospital

SAFETY BIOPSY NEEDLE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO EZ HUBER SAFETY INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

NuCath Wedge Pressure Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKING

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

REDON SET

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

JETCAN HUBER NEEEDLE SET

FDA 510(k)

FDA Class 2 ·General Hospital

MULTI-SNARE SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV

FDA 510(k)

FDA Class 2 ·Microbiology

GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I

FDA 510(k)

FDA Class 2 ·Microbiology

HERPES EIA TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEDIN TECH ZIRCONIA-CP10, SS1000

FDA 510(k)

FDA Class 2 ·Dental

Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·NORIAN SRS CEMENT

Wheelchair, Stair Climbing

FDA Pre-Market Approval

FDA Class 2 ·ACCESS MOBILITY SYSTEM

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·NORIAN SRS CEMENT