MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE

FDA 510(k)

FDA Class 1 ·Dental

Axiom PX

FDA 510(k)

FDA Class 2 ·Dental

Large Screws Range

FDA 510(k)

FDA Class 2 ·Orthopedic

Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

Volta AF-Xplorer

FDA 510(k)

FDA Class 2 ·Cardiovascular

LUNEAU STERILE TONOMETER SEPARATION PRISMS

FDA 510(k)

FDA Class 2 ·Ophthalmic

Scan Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Etest Ceftaroline (0.002 - 32ug/ml)

FDA 510(k)

FDA Class 2 ·Microbiology

Airlock osteosynthesis plate system

FDA 510(k)

FDA Class 2 ·Orthopedic

ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALUMINA HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

PERF-GEN Pulsatile Perfusion Solution

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HeartFocus (V.1.1.1)

FDA 510(k)

FDA Class 2 ·Radiology

DIXI Medical Microdeep Micro-Macro Depth Electrodes

FDA 510(k)

FDA Class 2 ·Neurology

GRAFTYS BCP

FDA 510(k)

FDA Class 2 ·Orthopedic

NAJA™ Ligament Correction System

FDA 510(k)

FDA Class 2 ·Orthopedic

Kontact Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental