Sysmex Automated Blood Coagulation Analyzer CS-5100

FDA 510(k)

FDA Class 2 ·Hematology

Sysmex Automated Blood Coagulation Analyzer CS-5100

FDA 510(k)

FDA Class 2 ·Hematology

Endophys Pressure Sensing Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

INFILL GRAFT DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2

FDA 510(k)

FDA Class 2 ·Immunology

INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls

FDA 510(k)

FDA Class 2 ·Hematology

NEUROTECH RECOVERY

FDA 510(k)

FDA Class 2 ·Neurology

ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT

FDA 510(k)

FDA Class 2 ·Cardiovascular

INJEKT CYSTO FLEXIBLE INJECTION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PRISM ACQUIRE PRISM PROCESS PRISM VIEW

FDA 510(k)

FDA Class 2 ·Radiology

MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL

FDA 510(k)

FDA Class 2 ·General Hospital

MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L

FDA 510(k)

FDA Class 2 ·General Hospital

1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1

FDA 510(k)

FDA Class 2 ·General Hospital

MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml

FDA 510(k)

FDA Class 2 ·Orthopedic

Radlink GPS Pro Imaging

FDA 510(k)

FDA Class 2 ·Radiology

BOBES TONOMETER

FDA 510(k)

FDA Class 2 ·Ophthalmic

BOBES SLIT LAMP

FDA 510(k)

FDA Class 2 ·Ophthalmic

1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2

FDA 510(k)

FDA Class 2 ·General Hospital