LAKE N/G EXTENSION SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS

FDA 510(k)

FDA Class 2 ·Dental

FACTOR IX DEFICIENT PLASMA, B9D -

FDA 510(k)

FDA Class 2 ·Hematology

UCENTUM

FDA 510(k)

FDA Class 2 ·Orthopedic

MGA-IR SIDESTREAM PCO2 MODULE

FDA 510(k)

FDA Class 2 ·Anesthesiology

STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

SOFTTOUCH(R) GUIDING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Corelink Foundation 3D Anterior Lumbar System

FDA 510(k)

FDA Class 2 ·Orthopedic

DYNAFLEX

FDA 510(k)

FDA Class 2 ·Dental

RHYTHM VIEW

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM

FDA 510(k)

FDA Class 2 ·Microbiology

SOLDER GPW

FDA 510(k)

FDA Class 2 ·Dental

XOMED MANDIBULAR TRAY

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

MULTICHEM (R) TOTAL BILIRUBIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GLUMA(TM) BONDING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

CoreLink F3D™ Lateral System

FDA 510(k)

FDA Class 2 ·Orthopedic