SmileAlign Orthodontic Aligner System

FDA 510(k)

FDA Class 2 ·Dental

Temperature Probe

FDA 510(k)

FDA Class 2 ·General Hospital

VISCO SOFT CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

THE MARGRON HIP REPLACEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

DailyMate Orthodontic Aligner System

FDA 510(k)

FDA Class 2 ·Dental

GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

KINGTECH FOREHEAD THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

Finger Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

KINGTECH DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Elecsys free PSA

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·OraQuick HCV Rapid Antibody Test

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·OraQuick HCV Rapid Antibody Test

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·COMPLETE BRAND LUBRICATING AND REWETTING DROPS

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·NaviStar Catheter, NaviStar RMT Catheter, EZ Steer Nav Catheter, Interface Cables