System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·CEA-ROCHE(R) EIA

MASTER & FRANK SURGICAL DRAPES (STERILE)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PANTHEON SPINAL IBFD SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

STS 701 TRANSPORT STRETCHER

FDA 510(k)

FDA Class 2 ·General Hospital

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ARCHITECT Anti-HCV Reagent Kit, Alinity i Anti-HCV Reagent Kit

SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS

FDA 510(k)

FDA Class 2 ·Ophthalmic

CAVERMAP SURGICAL AID

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MITEK MINI ANCHOR, MODIFICATION

FDA 510(k)

FDA Class 2 ·Orthopedic

BRUN SELECTIVE AND FLUSH ANGIOGRAPHIC CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MITEK MINI ANCHOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MITEK ANCHOR(TM)

FDA 510(k)

FDA Class 2 ·Orthopedic

M500-100 SHARPS CONTAINER

FDA 510(k)

FDA Class 2 ·General Hospital

T-FIX™ 3DSI Joint Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

VARICELLA ZOSTER VIRUS

FDA 510(k)

FDA Class 2 ·Microbiology

MEDPOR OCULAR SCREW & ACCESSORIES

FDA 510(k)

FDA Class 2 ·Ophthalmic

SOCKET GRAFT

FDA 510(k)

FDA Class 2 ·Dental

DUREX COLORS AND SCENTS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GRAHAM-FIELD SALINE ELECTROLYTE GEL

FDA 510(k)

FDA Class 2 ·Neurology

Ochsner Connected Inhaler Sensor

FDA 510(k)

FDA Class 2 ·Anesthesiology