3TEST GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ApolloVue S100 Image System

FDA 510(k)

FDA Class 2 ·Radiology

MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY

FDA 510(k)

FDA Class 2 ·Anesthesiology

VISCO SOFT CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

MAXIMED EXICHEK TD-4224 BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IDOC UPPER ARM ATTACHED BLOOD PRESSURE AND PULSE RATE MONITOR, MODEL ID-42A/ID-43A

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

AmCAD-UV

FDA 510(k)

FDA Class 2 ·Radiology

TEMP SCAN

FDA 510(k)

FDA Class 2 ·General Hospital

ACU-STIM TENS, AP-101082T

FDA 510(k)

FDA Class 2 ·Neurology

FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·Neurology

LM-9300 ELMA Lithotripter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A)

FDA 510(k)

FDA Class 2 ·Ophthalmic

XeliteMed VertehighFix High Viscosity Spinal Bone Cement

FDA 510(k)

FDA Class 2 ·Orthopedic

ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210

FDA 510(k)

FDA Class 2 ·Anesthesiology

SURGICAL FACE MASK; SURGICAL FACE MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOTECH POWERED WHEELCHAIR, C650PW

FDA 510(k)

FDA Class 2 ·Physical Medicine

Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator

FDA 510(k)

FDA Class 2 ·Neurology