HBL Blade Assembly

FDA 510(k)

FDA Class 2 ·Orthopedic

CALCIUM REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Clearform Aligners

FDA 510(k)

FDA Class 2 ·Dental

EndeavorOTC

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ScioCardio ECG Transmitter

FDA 510(k)

FDA Class 2 ·Cardiovascular

SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)

FDA 510(k)

FDA Class 2 ·Anesthesiology

NIASTAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES)

FDA 510(k)

FDA Class 2 ·Ophthalmic

MLS ELECTROMYOGRAPHIC PREAMPLIFIER

FDA 510(k)

FDA Class 2 ·Physical Medicine

OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR)

FDA 510(k)

FDA Class 2 ·Ophthalmic

CLAY-PARK LABS, INC. - LUBRICATING JELLY

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IKNEE DISTAL FEMORAL CUTTING GUIDE

FDA 510(k)

FDA Class 2 ·Neurology

Ortho Aligner System

FDA 510(k)

FDA Class 2 ·Dental

EndeavorRx

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CREATININE REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

KIRSCHNER WIRES, STEINMAN PINS

FDA 510(k)

FDA Class 2 ·Orthopedic

ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT

FDA 510(k)

FDA Class 2 ·Immunology

ENDSNOR

FDA 510(k)

FDA Class 2 ·Dental