ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD

FDA 510(k)

FDA Class 2 ·Dental

ENI BLOOD UREA NITROGEN REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GLIDESHEATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

SafePath Suturing System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HPM-6000UF

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BHA100 Series Braun Clear Hearing Aid

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

INTRAUTERINE INSEMINATION CATHETERS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IntellaMap Orion High Resolution Mapping Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

M2376A DEVICELINK SYSTEM, MODEL M2376A

FDA 510(k)

FDA Class 2 ·Cardiovascular

THERMAL COAGULATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BELMONT HYPERTHERMIA PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

INNOVASIVE 10MM LINX HT LIGAMENT FASTENER

FDA 510(k)

FDA Class 2 ·Orthopedic

RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS)

FDA 510(k)

FDA Class 2 ·Neurology

PERIOGENIX

FDA 510(k)

FDA Class 2 ·Dental

RAICHEM MULTI-ANALYTE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IOB Temperature Management System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RAPIDTOX

FDA 510(k)

FDA Class 2 ·Clinical Toxicology