VIVOSIGHT TOPICAL OCT SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

VITROS Immunodiagnostic Products Syphilis Reagent Pack

FDA 510(k)

FDA Class 2 ·Microbiology

TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Genex Bone Graft Substitute

FDA 510(k)

FDA Class 2 ·Orthopedic

Solas OR

FDA 510(k)

FDA Class 2 ·Radiology

Venus Silk.expert

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ultravision™ Visual Field Clearing System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TAMPON, UNTREATED

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA

FDA 510(k)

FDA Class 2 ·Anesthesiology

ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer

FDA 510(k)

FDA Class 2 ·Orthopedic

CARDIORATER CR7

FDA 510(k)

FDA Class 2 ·Cardiovascular

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.

FDA 510(k)

FDA Class 2 ·Immunology

eFOLDi Scooter, Lite

FDA 510(k)

FDA Class 2 ·Physical Medicine

QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GENEX

FDA 510(k)

FDA Class 2 ·Orthopedic

AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

Vascutek Gelsoft Plus ERS Vascular Graft

FDA 510(k)

FDA Class 2 ·Cardiovascular

ODFS PACE

FDA 510(k)

FDA Class 2 ·Neurology