UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE

FDA 510(k)

FDA Class 2 ·Immunology

COLLAGEN NERVE CUFF

FDA 510(k)

FDA Class 2 ·Neurology

OSOM CARD PREGNANCY TEST, MODEL 103

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OSOM CLASSIC HCG-URINE TEST (115)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

FDA 510(k)

FDA Class 2 ·Neurology

Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Innonix Antiviral Child's Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FIBEROPTIC CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROTARY* POWERED SCALPEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

RADS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Access PCT

FDA 510(k)

FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241

FDA 510(k)

FDA Class 2 ·General Hospital

Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AGFA CR50.0

FDA 510(k)

FDA Class 2 ·Radiology