T3 Platform software

FDA 510(k)

FDA Class 2 ·Cardiovascular

BARD TAB ECG MONITORING ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MENICON SF-P

FDA 510(k)

FDA Class 2 ·Ophthalmic

OSOM INFLUENZA A&B TEST

FDA 510(k)

FDA Class 2 ·Microbiology

CANDEKA DUKATIR SETS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

DR180-II

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MALDI Biotyper CA System

FDA 510(k)

FDA Class 2 ·Microbiology

DUAL-LUMEN CATHETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VEGA SPAN SPINOUS PROCESS PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER

FDA 510(k)

FDA Class 2 ·Neurology

FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE

FDA 510(k)

FDA Class 2 ·Orthopedic

Optiflux Enexa F500 Dialyzer

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ZSFab Cervical Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

ACCU-FLO PRESSURE VALVE

FDA 510(k)

FDA Class 2 ·Neurology

STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)

FDA 510(k)

FDA Class 2 ·Cardiovascular

OnPoint Augmented Reality Spine System

FDA 510(k)

FDA Class 2 ·Neurology