CROWN & BRIDGE RESIN FOR FABRICAT/DE

FDA 510(k)

FDA Class 2 ·Dental

CROWN S BRIDGE RESIN

FDA 510(k)

FDA Class 2 ·Dental

ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN BAR/BZO/MTD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE

FDA 510(k)

FDA Class 2 ·Neurology

TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M

FDA 510(k)

FDA Class 2 ·Cardiovascular

Fundus Camera

FDA 510(k)

FDA Class 2 ·Ophthalmic

Medical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WAKO (TM) AUTOKIT GOT TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WIRION

FDA 510(k)

FDA Class 2 ·Cardiovascular

TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

A7 Anesthesia System

FDA 510(k)

FDA Class 2 ·Anesthesiology

CRYOPEN AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)

FDA 510(k)

FDA Class 2 ·Dental

Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer

FDA 510(k)

FDA Class 2 ·Cardiovascular

QUANTITATIVE EEG ANALYSIS SOFTWARE

FDA 510(k)

FDA Class 2 ·Neurology