KDG Abutments

FDA 510(k)

FDA Class 2 ·Dental

KDG ACETABULAR COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

DynaCAD

FDA 510(k)

FDA Class 2 ·Radiology

.DECIMAL PHOTON BLOCK

FDA 510(k)

FDA Class 2 ·Radiology

EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

SUDOSCAN

FDA 510(k)

FDA Class 2 ·Neurology

EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

UroNav System

FDA 510(k)

FDA Class 2 ·Radiology

FaceHeart Vitals Software Development Kit (FH vitals SDK)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)

FDA 510(k)

FDA Class 2 ·Anesthesiology

epoc Blood Analysis System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EPOC BLOOD ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EPOC CHLORIDE TEST AND EPOC CREATININE TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Eroxon

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTHERM TEMPORARY OCCLUSION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLOW DIRECTED THERMODILUTION BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular