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

OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS

FDA 510(k)

FDA Class 2 ·Ophthalmic

D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEMAGEN ENA SCL-70 KIT (EIA METHOD)

FDA 510(k)

FDA Class 2 ·Immunology

WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular