BioPlex 2200 25-OH Vitamin D Kit

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FLO-RESTER(R) VESSEL SIZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION

FDA 510(k)

FDA Class 2 ·Dental

NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)

FDA 510(k)

FDA Class 2 ·Neurology

WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014

FDA 510(k)

FDA Class 2 ·Orthopedic

BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS

FDA 510(k)

FDA Class 2 ·Physical Medicine

gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)

FDA 510(k)

FDA Class 2 ·General Hospital

BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TOP GUN

FDA 510(k)

FDA Class 2 ·General Hospital

BIOMEGA #423-B BLOOD PRESSURE & PULSE CK

FDA 510(k)

FDA Class 2 ·Cardiovascular

EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PURE-AID PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator

FDA 510(k)

FDA Class 2 ·Cardiovascular

IC-2A MRI ADULT/PEDIATRIC VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology