Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OCU-FLEX-53 SOFT CONTACT LENSES

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·PREFERRED PLUS 53 SOFT (HYDROPHILIC) ASPHERIC LENS

AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999

FDA 510(k)

FDA Class 2 ·Neurology

ELECTRODE FOR URINARY INCONTINENCE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Essence 55SP Large Monitor System

FDA 510(k)

FDA Class 2 ·Cardiovascular

UBI MAGIWEL(TM) ANA QUANTITATIVE

FDA 510(k)

FDA Class 2 ·Immunology

Endoscopic Water Pump

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Wireless TENS & EMS Unit

FDA 510(k)

FDA Class 2 ·Physical Medicine

SURGICAL GOWN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bipolar Coagulation Foreceps

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Locking device

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)

FDA 510(k)

FDA Class 2 ·Cardiovascular

OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip

FDA 510(k)

FDA Class 2 ·Cardiovascular

6MP Color LCD Monitor (C61W+)

FDA 510(k)

FDA Class 2 ·Radiology