UNILECT, MONITAB AND BIOTRACE-HR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MSB TENS ELECTRODES (DISPOSABLE)

FDA 510(k)

FDA Class 2 ·Neurology

MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES)

FDA 510(k)

FDA Class 2 ·Neurology

ECG ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEUTRALECT ADULT STANDARD, RETURN (REM) & PAEDIATRIC ELECTROSURGERY PLATE (MODIFICATION)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD, RETURN (REM)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOTRACE-N, NS, 410 AND RT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECOTABS

FDA 510(k)

FDA Class 2 ·Cardiovascular

DEEPVISON

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BUFFERED AEROSOL SALINE SOLUTION (BL-2700-NS9)

Alveoair Digital Spirometer

FDA 510(k)

FDA Class 2 ·Anesthesiology

VIA-GUARD

FDA 510(k)

FDA Class 2 ·General Hospital

ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LAPRO-LOADER(TM)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3

FDA 510(k)

FDA Class 2 ·Radiology

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4

FDA 510(k)

FDA Class 2 ·Radiology

AVC A/H5N1 FLU TEST

FDA 510(k)

FDA Class 2 ·Microbiology

Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664

FDA 510(k)

FDA Class 2 ·Radiology

REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE

FDA 510(k)

FDA Class 2 ·Orthopedic

Avicenna Roboflex

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology