DIAGNOSOFT HARP MODEL 2.06

FDA 510(k)

FDA Class 2 ·Radiology

QUICKSCREEN COCAINE 150 SCREENING TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CONDOM (PROPHYLACTIC)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Indigo® Aspiration System – Lightning Bolt Aspiration Tubing

FDA 510(k)

FDA Class 2 ·Cardiovascular

Arthrex SS VAL and VAL KreuLock™ Compression Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams

FDA 510(k)

FDA Class 2 ·Orthopedic

1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)

FDA 510(k)

FDA Class 2 ·Radiology

CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET

FDA 510(k)

FDA Class 2 ·Anesthesiology

NUVASIVE SPHERX II SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EVALVE STEERABLE GUIDE CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

QMED SELF ADHERING ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE

FDA 510(k)

FDA Class 2 ·Ophthalmic

VIDAS CEA (S) ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

PUREFILL OXYGEN COMPRESSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

EpiAccess System

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRI-FLOW CATHETER

FDA 510(k)

FDA Class 2 ·Neurology

FiberTak DR

FDA 510(k)

FDA Class 2 ·Orthopedic

MACMED PAEDIATRIC INTRAMEDULLARY NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic