ELPHA 2000

FDA 510(k)

FDA Class 2 ·Physical Medicine

MYOTEST - NERVE STIMULATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

CRAIGWELL MASTER HEARING AID MHA

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Wet Essential95 Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MEDICAL GRADE SILICONE BLOCK

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220

FDA 510(k)

FDA Class 2 ·Cardiovascular

SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101

FDA 510(k)

FDA Class 2 ·Cardiovascular

OIC External Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

TISMESH SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

FAQ™ (102)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME

FDA 510(k)

FDA Class 2 ·Orthopedic

ULTROID HEMORRHOID MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MATRIX MICROSON 410

FDA 510(k)

FDA Class 2 ·Physical Medicine

SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100

FDA 510(k)

FDA Class 2 ·Radiology

MICOR Lens Fragmentation System

FDA 510(k)

FDA Class 2 ·Ophthalmic

VEOLAR VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

GEODESIC EEG SYSTEM SERIES 100

FDA 510(k)

FDA Class 2 ·Neurology

GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000

FDA 510(k)

FDA Class 2 ·General Hospital

QUEST DIAGNOSTICS HAIRCHECK-DT (OPIATES)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology