OTI ORTHOPEDIC FASTENER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

3S INJECTOR-CT CONTRAST DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0

FDA 510(k)

FDA Class 2 ·Radiology

REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMMIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469

FDA 510(k)

FDA Class 2 ·General Hospital

TERUMO SENSIBEAD EIA TSH KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NEURO II-SE, MODELS: OR-DR-OR, OR-MB

FDA 510(k)

FDA Class 2 ·Radiology

ALCON SERIES 20000 LEGACY PHACOEMULSIFIER

FDA 510(k)

FDA Class 2 ·Ophthalmic

HOTLINE FLUID WARMER

FDA 510(k)

FDA Class 2 ·General Hospital

AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STRATA, MODEL V.O.95

FDA 510(k)

FDA Class 2 ·Radiology

CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST

FDA 510(k)

FDA Class 2 ·Immunology

FIAX LYME M TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING

FDA 510(k)

FDA Class 2 ·Cardiovascular

GUIDE WIRE FOR LAPOROSCOPIC USE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CHARNLEY TYPE HIP PROTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

SCEPTOR GRAM-POSITIVE BREAKPOINT/ID PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

WIESLAB CAP PR-3 ANCA

FDA 510(k)

FDA Class 2 ·Immunology

VORICONAZOLE 1UG BBL SENSI-DISC

FDA 510(k)

FDA Class 2 ·Microbiology

APPRAISE-HRI

FDA 510(k)

FDA Class 2 ·Cardiovascular