Electronic Stethoscope DS3011A

FDA 510(k)

FDA Class 2 ·Cardiovascular

Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II

FDA 510(k)

FDA Class 2 ·Orthopedic

VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA

FDA 510(k)

FDA Class 2 ·Cardiovascular

GLUCOMANAGER DATA MANAGEMENT SOFTWARE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

WEGO-PGLA RAPID

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DeepCT

FDA 510(k)

FDA Class 2 ·Radiology

EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HCV TEST VERSION 2.0

CAPILLARY SAMPLE LINE

FDA 510(k)

FDA Class 2 ·Anesthesiology

CO2/02 MONITOR MULTINEX

FDA 510(k)

FDA Class 2 ·Anesthesiology

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ROCHE MOLECULAR SYSTEMS COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS ANTI-HCV

Carex Hybrid Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GEMORE TRUE SINE INTERFERENTIAL STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

GEM-STIM COMBO STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology