ALCOHOL PAD

FDA 510(k)

FDA Class 2 ·General Hospital

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·MICROSCAN(R)ALANINE-AMC R GRAM NEG.MIC PANELS

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·MICROSCAN(R)ALANINE-AMC R GRAM NEG.MIC PANELS

BowTie™ SI Joint Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

DISTAL RADIO-ULNAR JOINT IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

DETRUSAN 500

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER

FDA 510(k)

FDA Class 2 ·Neurology

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

APOFIX CERVICAL SPINE FIXATION

FDA 510(k)

FDA Class 2 ·Orthopedic

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

FDA 510(k)

FDA Class 2 ·Neurology

WAMPOLE HS-CRP ELISA

FDA 510(k)

FDA Class 2 ·Immunology

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

FACTOR II (PROTHROMBIN) G20210A KIT

FDA 510(k)

FDA Class 2 ·Hematology