N-ASSAY TIA IGM

FDA 510(k)

FDA Class 2 ·Immunology

Standard Sterilizable Tray

FDA 510(k)

FDA Class 2 ·General Hospital

BILIRUBIN (DIRECT)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Anchor Bolt (as an accessory to Depth Electrodes)

FDA 510(k)

FDA Class 2 ·Neurology

GLUCOSE (HEXOKINASE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LACTATE DEHYDROGENASE (LDH-L)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ALBUMIN, BROMCRESOL GREEN DYE-BINDING

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LAPAROSCOPY SET

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VibrantVue Scleral Saline

FDA 510(k)

FDA Class 2 ·Ophthalmic

AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY

FDA 510(k)

FDA Class 2 ·Ophthalmic

OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

STERILE DISPOSABLE PN DRAPE SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SMARTbase Abutment System

FDA 510(k)

FDA Class 2 ·Dental

INTELLISPACE ECG

FDA 510(k)

FDA Class 2 ·Cardiovascular

COOLCUBE COOLPEN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AT64 SCR

FDA 510(k)

FDA Class 2 ·Neurology

CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3

FDA 510(k)

FDA Class 2 ·Hematology

CUFF GUARD

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SOLCO SILICONE RESUSCITATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology