HEMODIALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENK FIBEROPTIC ATOMIZER SET

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES

FDA 510(k)

FDA Class 2 ·Anesthesiology

FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber

FDA 510(k)

FDA Class 2 ·Anesthesiology

ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000

FDA 510(k)

FDA Class 2 ·Anesthesiology

BLUE 400; BLUE 400 S

FDA 510(k)

FDA Class 2 ·Neurology

LANX SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

i-Cut

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CAPO BULK FILL

FDA 510(k)

FDA Class 2 ·Dental

MANUJET III

FDA 510(k)

FDA Class 2 ·Anesthesiology

INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)

FDA 510(k)

FDA Class 2 ·Radiology

LANX ANTERIOR PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)

FDA 510(k)

FDA Class 2 ·Orthopedic

LANX SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PLV CONTINUUM VENTILATOR, MODEL P2000

FDA 510(k)

FDA Class 2 ·Anesthesiology

SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet

FDA 510(k)

FDA Class 2 ·Anesthesiology

AI-Rad Companion (Cardiovascular)

FDA 510(k)

FDA Class 2 ·Radiology

Fixtemp® C&B 4:1

FDA 510(k)

FDA Class 2 ·Dental

GENESIS (MS-P02-GEN)

FDA 510(k)

FDA Class 2 ·Physical Medicine

PLV CONTINUUM VENTILATOR, MODEL P1000

FDA 510(k)

FDA Class 2 ·Anesthesiology