VENTSTREAM DRUG NEBULIZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL

FDA 510(k)

FDA Class 2 ·Orthopedic

NEUROSIGN 100 IMPEDANCE METER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

JUVORA Dental Disc, Ceramill PEEK by JUVORA

FDA 510(k)

FDA Class 2 ·Dental

RESTORE-X

FDA 510(k)

FDA Class 2 ·Dental

SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Urethrotech UCD

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Revitive Medic Coach (Model Number 5575AQ)

FDA 510(k)

FDA Class 2 ·Physical Medicine

HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER

FDA 510(k)

FDA Class 2 ·Immunology

Oxehealth Vital Signs

FDA 510(k)

FDA Class 2 ·Cardiovascular

EchoGo Heart Failure

FDA 510(k)

FDA Class 2 ·Cardiovascular

NeoGen PSR System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016

FDA 510(k)

FDA Class 2 ·Dental

SATURN ACTIVE LASER SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FLEXILOG LS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Otowave 202 Portable Tympanometer

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SMARTSIGNS MINPULSE

FDA 510(k)

FDA Class 2 ·Cardiovascular

XVI R4.5

FDA 510(k)

FDA Class 2 ·Radiology