iCare APP

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIA SCREEN 10 WAY REAGENT STRIPS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1400106; 4 250 ML CAT. # 1400107; WIENER LAB. GILICEMIA ENZCA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE

FDA 510(k)

FDA Class 2 ·General Hospital

SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL

FDA 510(k)

FDA Class 2 ·Immunology

Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN

FDA 510(k)

FDA Class 2 ·Radiology

WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS

FDA 510(k)

FDA Class 2 ·Orthopedic

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

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