S-Line

FDA 510(k)

FDA Class 2 ·General Hospital

CARBOXYLATE CEM, PHOSPHATE CEM

FDA 510(k)

FDA Class 2 ·Dental

PHILIPS ESSENTA DR

FDA 510(k)

FDA Class 2 ·Radiology

N Latex FLC kappa, N Latex FLC lambda

FDA 510(k)

FDA Class 2 ·Immunology

SICAT Endo

FDA 510(k)

FDA Class 2 ·Radiology

IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DigitalDiagnost C90

FDA 510(k)

FDA Class 2 ·Radiology

Clearblue ® Early Pregnancy Test

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COSMIC SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ulrichINJECT CT motion

FDA 510(k)

FDA Class 2 ·Cardiovascular

VP-1000; MED CAM 100; VP-3000A; MED CAM 300

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

Automated Blood Coagulation Analyzer CS-2500

FDA 510(k)

FDA Class 2 ·Hematology

GOLDEN GATE ANTERIOR PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SINGLE USE BALLOON DILATOR MAXPASSTM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Sysmex Automated Blood Coagulation Analyzer CS-2100i

FDA 510(k)

FDA Class 2 ·Hematology

KETTOSIL AND SILGINAT

FDA 510(k)

FDA Class 2 ·Dental

MobileLink Acetabular Cup System - inhouse coatings

FDA 510(k)

FDA Class 2 ·Orthopedic

ULTRA Telescopes

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology