QAB2A IGG ELISA KIT

FDA 510(k)

FDA Class 2 ·Immunology

FETAL PILLOW

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Tristel OPH

FDA 510(k)

FDA Class 2 ·General Hospital

NEXA Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS

FDA 510(k)

FDA Class 2 ·Ophthalmic

CamAPS FX

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NLITE SYSTEM,MODEL A00-1051

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CRAIGWELL MASTER HEARING AID MHA

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Ova+ (K-OVAP-USA)

FDA 510(k)

FDA Class 2 ·Neurology

Cydar EV

FDA 510(k)

FDA Class 2 ·Radiology

RANDOX METABOLITE (EDDP) ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DRYSPOT INFECTIOUS MONONUCLEOSIS KIT

FDA 510(k)

FDA Class 2 ·Immunology

CONTINUOUS CARDIAC OUPUT MONITOR, TRUCCOM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CR 280/45, CR281/4 DEFIBRILLATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

AXIS-SHIELD ANTI-CCP

FDA 510(k)

FDA Class 2 ·Immunology

MLCI2

FDA 510(k)

FDA Class 2 ·Radiology

QUANTASE PHE/GAL SCREENING ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OSCAR BONE RESECTOR

FDA 510(k)

FDA Class 2 ·Orthopedic