PREVISION HIP SYSTEM WITH RECON RING

FDA 510(k)

FDA Class 2 ·Orthopedic

PWD Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VALIDATE Heparin Calibration Verification/Linearity Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

DYNAMIC GAS SCAVENGING SYSTEM (DGSS)

FDA 510(k)

FDA Class 2 ·Anesthesiology

3D ASL

FDA 510(k)

FDA Class 2 ·Radiology

OAKTREE Anterior Lumbar Plate and Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

USS System

FDA 510(k)

FDA Class 2 ·Orthopedic

sagAlign Lumbar Cage System (Various PNs)

FDA 510(k)

FDA Class 2 ·Orthopedic

K-ASSAY CRP (Ver.2)

FDA 510(k)

FDA Class 2 ·Immunology

Tangis Anterior Cervical Plate

FDA 510(k)

FDA Class 2 ·Orthopedic

CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PILLAR PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

B-SLIDE PREGNATE PREGNANCY TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EPIFLO-28

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism

FDA 510(k)

FDA Class 2 ·Ophthalmic

C-PORT

FDA 510(k)

FDA Class 2 ·General Hospital

LATEST RF KIT FOR RHEUMATOID FACTOR

FDA 510(k)

FDA Class 2 ·Immunology

DIAGNOSTICS PH ELECTRODE CLEANING SOLUT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MIS Bunion Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic