OSW Aligner System

FDA 510(k)

FDA Class 2 ·Dental

PAP STAIN, OG-6

FDA 510(k)

FDA Class 1 ·Hematology

PAPANICOLAOU STIAN OG-6

FDA 510(k)

FDA Class 1 ·Hematology

ORAGENE DX OGD-500.001

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DNA/RNA Shield SafeCollect Saliva Collection kit

FDA 510(k)

FDA Class 2 ·Microbiology

DNA/RNA Shield Collection Tube

FDA 510(k)

FDA Class 2 ·Microbiology

MIVI Mi-AXUS Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2

FDA 510(k)

FDA Class 2 ·General Hospital

VersaD Delivery Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EUCLID (TM) TIER 1-GW ACCESS SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6

FDA 510(k)

FDA Class 1 ·Hematology

PAPINCOLABU STAIN EA-36/50/65 & OG-6

FDA 510(k)

FDA Class 1 ·Hematology

Suction Irrigation Tubing Set

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Bladeless Trocar; Bladed Trocar; Hasson Trocar

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CONDOMS (RUBBER CONTRACEPTIVES)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

1570 - FETAL BLOOD SAMPLING KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

READS ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology

ACTIVATED PARTIAL THROMBOPLASTIN TIME

FDA 510(k)

FDA Class 2 ·Hematology

PAKOSTAT II

FDA 510(k)

FDA Class 2 ·Radiology