Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·NATUREVUE CONTACT LENSE

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR

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 ·DURASOFT CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·PERMATINT(R)

Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EARLOOP FACE MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES

FDA 510(k)

FDA Class 2 ·Neurology

Med-link Temperature Probes

FDA 510(k)

FDA Class 2 ·General Hospital

GEMORE TRUE SINE INTERFERENTIAL STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

GEMORE MUSCLE CONDITIONER;

FDA 510(k)

FDA Class 2 ·Physical Medicine

GEM-STIM COMBO STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP

FDA 510(k)

FDA Class 2 ·Neurology

GEM-TWIN TENS/ MODELS GM3XY/Z

FDA 510(k)

FDA Class 2 ·Neurology

GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)

FDA 510(k)

FDA Class 2 ·Neurology

Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.

FDA 510(k)

FDA Class 2 ·Physical Medicine

SD-602 SD MODE 11, SD-603 SD MOD 111

FDA 510(k)

FDA Class 2 ·Neurology

STAT-TENS

FDA 510(k)

FDA Class 2 ·Neurology