AXSYM PHENOBARBITAL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MULTI-PURPOSE CONTROL SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

OSTEO CERCLAGE WIRE

FDA 510(k)

FDA Class 2 ·Orthopedic

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PULSION PICCO PLUS, MODEL 8100

FDA 510(k)

FDA Class 2 ·Cardiovascular

ISO-GARD CLEARAIR MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

MEDSCI 3% GLUTARALDEHYDE

FDA 510(k)

FDA Class 2 ·General Hospital

TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T

FDA 510(k)

FDA Class 2 ·Orthopedic

MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

WILTEK BALLOON STONE EXTRACTOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ADD'L INDICATION FOR OCTYLDENT 2-OCTYL CRANOACRY.

FDA 510(k)

FDA Class 2 ·Dental

SOEHENDRA STENT RETRIEVER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MCS Bone Graft

FDA 510(k)

FDA Class 2 ·Orthopedic

OT IGG SORBENT

FDA 510(k)

FDA Class 2 ·Immunology

TOUCH TEAR IGE MICROASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

SOEHENDRA LITHOTRIPSY SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KRYPTOSOL (SUN LAMP)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VACUETTE® QUICKSHIELD Complete (Plus)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Senhance Surgical System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology