ACA DU PONT URINE COCAINE METABOLITE (U COC)SCREEN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION TPSA CALIBRATOR, MODEL #RC459

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STRATUS CS ACUTE CARE D-DIMER

FDA 510(k)

FDA Class 2 ·Hematology

DU PONT TOBRAMYCIN ASSAY REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CYCLOSPORINE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

THYROID STIMULATING HORMONE METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Stimulator, Salivary System

FDA Pre-Market Approval

FDA Class 2 ·SALITRON SYSTEM

Bone Grafting Material, For Dental Bone Repair

FDA Pre-Market Approval

FDA Class 2 ·PERI-OSS

Bone Grafting Material, For Dental Bone Repair

FDA Pre-Market Approval

FDA Class 2 ·CERASORB DENTAL

QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)

FDA 510(k)

FDA Class 2 ·Anesthesiology

NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

myQA iON

FDA 510(k)

FDA Class 2 ·Radiology

VISULAS combi

FDA 510(k)

FDA Class 2 ·Ophthalmic

RECON system

FDA 510(k)

FDA Class 2 ·Orthopedic

FUTURABOND M+

FDA 510(k)

FDA Class 2 ·Dental

Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System

FDA 510(k)

FDA Class 2 ·Neurology

SURGIFLATOR 20

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SORING MBC200/BCC140

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery