PHAKOSYSTEMS MODEL CES 4100

FDA 510(k)

FDA Class 2 ·Ophthalmic

IMMUNOCORP COATED TUBE IRMA HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SEKURE Acetaminophen L3K Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GenePOC Carba

FDA 510(k)

FDA Class 2 ·Microbiology

MUELLER HINTON AGAR WITH 5% SHEEP BLOOD

FDA 510(k)

FDA Class 2 ·Microbiology

MEDIBYTE, MODEL MP8

FDA 510(k)

FDA Class 2 ·Anesthesiology

INVENTUS IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

ISG VIEWING WAND

FDA 510(k)

FDA Class 2 ·Neurology

SAM CRRT Unit, SAM Cassette CRRT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EFILM VIDEO

FDA 510(k)

FDA Class 2 ·Radiology

MediClear PreOp

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VAS-CATH OPTI-PLAST 5F PERIPHERAL ANGIOPLASTY CATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

ISG MEDICAL IMAGING FAMILY OF WORKSTATIONS (MIFW)

FDA 510(k)

FDA Class 2 ·Radiology

MPowRx Snoring Solution (also known as Good Morning Snore Solution)

FDA 510(k)

FDA Class 2 ·Dental

THE LAITINEN STEREOTACTIC SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING

FDA 510(k)

FDA Class 2 ·Radiology

ADI/B/*/HA-2 STAGE OSSEO. HYDRO. DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PRECI-JET 50

FDA 510(k)

FDA Class 2 ·General Hospital

Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx

FDA 510(k)

FDA Class 2 ·Clinical Toxicology