VX650

FDA 510(k)

FDA Class 2 ·Ophthalmic

Dextile Anatomical Mesh

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Chronos®

FDA 510(k)

FDA Class 2 ·General Hospital

MR Diffusion Perfusion Mismatch V1.0

FDA 510(k)

FDA Class 2 ·Radiology

Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Fetal EchoScan

FDA 510(k)

FDA Class 2 ·Radiology

PASS LP Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

SenoBright HD

FDA 510(k)

FDA Class 2 ·Radiology

Hepatic VCAR

FDA 510(k)

FDA Class 2 ·Radiology

FIDIS CELIAC

FDA 510(k)

FDA Class 2 ·Immunology

Tornier Pyrocarbon Humeral Head

FDA 510(k)

FDA Class 2 ·Orthopedic

IMPLANET Spine System (ISS)

FDA 510(k)

FDA Class 2 ·Orthopedic

IB3D™ PL Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

SMILERS

FDA 510(k)

FDA Class 2 ·Dental

ROSA ONE Brain application

FDA 510(k)

FDA Class 2 ·Neurology

CT Perfusion V1.0

FDA 510(k)

FDA Class 2 ·Radiology

SOFAMOR ORFIL SPINE FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Exciplex308nm

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery