HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Da Vinci Monopolar and Bipolar Adapters (378896)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

N-ASSAY TIA APO A1 TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197

FDA 510(k)

FDA Class 2 ·Orthopedic

LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)

FDA 510(k)

FDA Class 2 ·Immunology

SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

KMI WRIST FUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TRIPLE-FIX SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ADVANTAGE HCG TEST (URINE/SERUM)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEVAMATIC 3

FDA 510(k)

FDA Class 2 ·Radiology

ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SOVEREIGN BIPOLAR INSTRUMENTS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MENLO CARE AQUASTENT SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PHENOBARBITAL CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology