Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TorqVue Low Profile Delivery Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Sublime Radial Access 018 RX Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

LA MONT VIDEO PATIENT MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

YIXIN SAFETY SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P

FDA 510(k)

FDA Class 2 ·Cardiovascular

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM

AMPLATZER TorqVue 45x45 Delivery Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD Intraosseous Infusion System

FDA 510(k)

FDA Class 2 ·General Hospital

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Versant HCV Genotype 2.0 Assay (LiPA)

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·MFL5000 & DORNIER LITHOTRIPTERS (STATIOINARY & TRANSPORTABLE)

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT Anti-HCV (LN 1L79)

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS

EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101)

FDA 510(k)

FDA Class 2 ·Neurology

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·ECONOLITH(TM) LITHOTRIPTER

Cyclosporine Radioimmunoassay

FDA Pre-Market Approval

FDA Class 2 ·SANDIMMUNE(R) RADIOIMMUNOASSAY KIT

GT990402 DIGITAL THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

TIANJIN MEDIS DISPOSABLE INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

MODEL GT980201 ELECTRONIC THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER COMPACT S) AND DORNIER LITHOTRIPTER (STATIONARY & TRANSPORTABLE