EBI XFIX DFS OPTIROM ELBOW FIXATOR

FDA 510(k)

FDA Class 2 ·Orthopedic

EUROIMMUN ANTI-SLA/LP ELISA(LGG)

FDA 510(k)

FDA Class 2 ·Immunology

OMNIFIT(R) TOTAL KNEE SYSTEM (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Orthopedic

SIREMOBIL COMPACT

FDA 510(k)

FDA Class 2 ·Radiology

BOLTON PTA CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

VISUALINE METHADONE DIPSTRIPTEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OCO DENTAL IMPLANT (5.0MM DIAMETER)

FDA 510(k)

FDA Class 2 ·Dental

NEOPHOR-MC

FDA 510(k)

FDA Class 2 ·Physical Medicine

PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OMEGA 21 SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BARD BIOPTY BIOPSY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PASSPORT 5L-CE MODEL 0998-00-0131XXX

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO ABUSCREEN ONLINE BARBITURATES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LASETTE LASER SKIN PERFORATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GAMMA LOCKING NAIL - LONG LENGTH

FDA 510(k)

FDA Class 2 ·Orthopedic

FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)

FDA 510(k)

FDA Class 2 ·Ophthalmic

AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SIDESTREAM PLUS

FDA 510(k)

FDA Class 2 ·Anesthesiology