SENSI

FDA 510(k)

FDA Class 2 ·Cardiovascular

HIP JOINT METAL/POLYMER SEMI-CONSTRAINED PROTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

RENEGADE WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

CALCAMEA PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

HDX DIGITAL IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

IMZ - DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

SELF SEAL STERILIZATION POUCH

FDA 510(k)

FDA Class 2 ·General Hospital

MARK VII THERMOREGULATION ASSIST SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

EPINEED EPIDURAL NEEDLE

FDA 510(k)

FDA Class 2 ·Anesthesiology

Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)

FDA 510(k)

FDA Class 2 ·Cardiovascular

VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D

FDA 510(k)

FDA Class 2 ·Ophthalmic

SENSIBEAD EIA IGE KIT

FDA 510(k)

FDA Class 2 ·Immunology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND CIPROFLOXACIN-0.25 - 4 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE

FDA 510(k)

FDA Class 2 ·Microbiology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN-GP DETECTION OF VRSA.

FDA 510(k)

FDA Class 2 ·Microbiology

OBF MODEL 112 VACUUM CUP SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic

BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

IOB Warming Blankets

FDA 510(k)

FDA Class 2 ·Cardiovascular

RAPIDONE-OXY TEST

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMG MODEL SUA01 SUCTION UNIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery