EHC500 DESKTOP PATIENT STATION, MODEL EHC500

FDA 510(k)

FDA Class 2 ·Cardiovascular

EUROPA™ Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

PSI-TEC PERISTALTIC INFILTRATION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

SafeBreak® Vascular

FDA 510(k)

FDA Class 2 ·General Hospital

INFUSET W/HUBER NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

GS-1000 GRASPING FORCEP, 5MM, INSULATED

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III

FDA 510(k)

FDA Class 2 ·Cardiovascular

UltraCor™ Twirl™ Breast Tissue Marker

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SCREENERS BENZODIAZEPINE (BZD) TEST, DRUG SCREEN DIP BENZODIAZEPINE (BZD) TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOFT CONTACT LENS

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER MODELS MFL5000 MOBILE LITHOTRIPTER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER, MODEL HM3

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOFT CONTACT LENS

Suture, Nonabsorbable, Synthetic, Polypropylene

FDA Pre-Market Approval

FDA Class 2 ·GORE-TEX(R) SUTURE

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH