HOT/ICE DUAL FUNCTION EQUIPMENT

FDA 510(k)

FDA Class 2 ·Physical Medicine

ARTHROSCOPIC ACL CANNULATED DRILLS AND SLEEVES

FDA 510(k)

FDA Class 2 ·Orthopedic

Atlas Spine Lateral Expandable Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

Frida™ Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

DINAMAP COMPACT MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELISIO-H HEMODIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BPS - Bone Fragment Fixation Plates, Screws and Washers

FDA 510(k)

FDA Class 2 ·Orthopedic

1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT)

FDA 510(k)

FDA Class 2 ·Anesthesiology

CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1

FDA 510(k)

FDA Class 2 ·Hematology

Exactech® Novation® Crown Cup®

FDA 510(k)

FDA Class 2 ·Orthopedic

MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus)

FDA 510(k)

FDA Class 2 ·Radiology

ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS

FDA 510(k)

FDA Class 2 ·Dental

Arthrex iBalance TKA System

FDA 510(k)

FDA Class 2 ·Orthopedic

ANTITHROMBIN III CHROMOGENIC ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD

FDA 510(k)

FDA Class 2 ·Anesthesiology

INVOTEC MICROSCOPE DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OCHSNER ULP BIFURCATION VASCULAR PROTHESIS

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMITHWICK CAROTID SHUNT

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRACKRECORD DATA MANAGEMENT SOFTWARE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ENVOY AND VISTA BRITE TIP

FDA 510(k)

FDA Class 2 ·Cardiovascular