INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5

FDA 510(k)

FDA Class 2 ·Hematology

Atellica® IM High-Sensitivity Troponin I (TnIH)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC

FDA 510(k)

FDA Class 2 ·Immunology

Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GentleCath Glide Intermittent Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

RSI FEMORAL GUIDING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT

FDA 510(k)

FDA Class 2 ·General Hospital

AMICAS VISION SERIES PACS, MODEL 4.3

FDA 510(k)

FDA Class 2 ·Radiology

AMICAS PACS, VERSION 6.0

FDA 510(k)

FDA Class 2 ·Radiology

MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

Emit® II Plus Buprenorphine Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GPC Intraheal Intramedullary Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic