INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACCUSYTE 3D Fiducial Marker

FDA 510(k)

FDA Class 2 ·Radiology

Jac-Cell Medic testers

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PULSE-AID DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ProRad 2FC and ProRad 3NC Stationary Radiographic Systems

FDA 510(k)

FDA Class 2 ·Radiology

INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES; MODELS ATI014 & ATI014 FC

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS PTCA DILITATION CARTHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED(R) PTCA CATHETER

Advanced LumFix Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

AirStrip ONE Web Client with Alarm Communication Management (ACM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

oCare Wrist Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB

FDA 510(k)

FDA Class 2 ·Immunology

WAKO AUTOKIT LP(A)/ RA,500/1000,

FDA 510(k)

FDA Class 2 ·Immunology

WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA

FDA 510(k)

FDA Class 2 ·Immunology

WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET

FDA 510(k)

FDA Class 2 ·Immunology

WAKO AUTOKIT LP(A)

FDA 510(k)

FDA Class 2 ·Immunology

WAKO AUTOKIT APO B

FDA 510(k)

FDA Class 2 ·Immunology

Lp(a) Ultra

FDA 510(k)

FDA Class 2 ·Immunology

LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH

FDA 510(k)

FDA Class 2 ·Immunology

N LATEX LP(A)

FDA 510(k)

FDA Class 2 ·Immunology