CK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALCYON 300I (WITH ISE MODULE) ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DETRUSAN 500

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PUREFILL OXYGEN COMPRESSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MOUTH-TO-MASK RESUSCITATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

COMPLETE CPR KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS

FDA 510(k)

FDA Class 2 ·Neurology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·BREAST COMPANION SOFTWARE SYSTEM

A O FIBER OPTIC ILLUMINATOR, 1185B

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

A O FIBER OPTIC ILLUMINATION, 1185A

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING

FDA 510(k)

FDA Class 2 ·Hematology

INVADER FACTOR II

FDA 510(k)

FDA Class 2 ·Hematology

cobas Factor II and Factor V Test

FDA 510(k)

FDA Class 2 ·Hematology

Xpert® FII & FV

FDA 510(k)

FDA Class 2 ·Hematology

FACTOR V LEIDEN KIT

FDA 510(k)

FDA Class 2 ·Hematology

INFINITI SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

INVADER FACTOR V

FDA 510(k)

FDA Class 2 ·Hematology