Contact Lens Case Round Glasses

FDA 510(k)

FDA Class 2 ·Ophthalmic

Afinion HbA1c Dx on Afinion 2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

Afinion HbA1c Dx

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Alere Afinion HbA1c, Alere Afinion AS100 Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

Digital Flat Panel Detector

FDA 510(k)

FDA Class 2 ·Radiology

Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use

FDA 510(k)

FDA Class 2 ·General Hospital

Disposable Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TENS device-EmeTerm, CinvStop

FDA 510(k)

FDA Class 2 ·Neurology

Safety Blood Collection Sets for Single Use

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe

FDA 510(k)

FDA Class 2 ·General Hospital

TENS device-HeadaTerm 2 (Model: YF-HT2)

FDA 510(k)

FDA Class 2 ·Neurology

Single-use Extraction Baskets

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OGYILI TENS/NMES Stimulator

FDA 510(k)

FDA Class 2 ·Neurology

TRANSTEK GLASS BODY FAT ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ensmile

FDA 510(k)

FDA Class 2 ·Dental

Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)

FDA 510(k)

FDA Class 2 ·General Hospital

SMARTLOC SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic