vWF Ag

FDA 510(k)

FDA Class 2 ·Hematology

N Latex FLC kappa assay, N Latex FLC lambda assay

FDA 510(k)

FDA Class 2 ·Immunology

Color Liquid, Vita Liquid

FDA 510(k)

FDA Class 2 ·Dental

ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray

FDA 510(k)

FDA Class 2 ·Radiology

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)

FDA 510(k)

FDA Class 2 ·Immunology

N Latex Cystatin C; N Protein Standard UY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N Latex FLC kappa, N Latex FLC lambda

FDA 510(k)

FDA Class 2 ·Immunology

Sysmex Automated Blood Coagulation Analyzer CS-5100

FDA 510(k)

FDA Class 2 ·Hematology

ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA

FDA 510(k)

FDA Class 2 ·Dental

Sysmex Automated Blood Coagulation Analyzer CS-5100

FDA 510(k)

FDA Class 2 ·Hematology

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

DADE BEHRING N HIGH SENSITIVITY CRP ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

POREX(TM) EAR PROSTHESIS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CANAL WALL PROSTHESIS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ePTFE-Coated Auricular Implant

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ATTIC DEFECT PLATE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT

FDA 510(k)

FDA Class 2 ·Dental