InnoVoyce Laser Fiber

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS

FDA 510(k)

FDA Class 2 ·Ophthalmic

APEX MODULAR ZIRCONIA FEMORAL HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

ECC.O SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

CERESTORE CORE MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

INTERCEPTRE LAPAROSCOPIC INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PREDICTA ERYTHROPOIETIN KIT

FDA 510(k)

FDA Class 2 ·Hematology

DRITRAINER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT

FDA 510(k)

FDA Class 2 ·Immunology

PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

POLYURETHANE CATHETER FOR THE INFUSE-A-PORT

FDA 510(k)

FDA Class 2 ·General Hospital

INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5

FDA 510(k)

FDA Class 2 ·Cardiovascular

FRESENIUS 2008T HEMODIALYSIS MACHINE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CAVERMAP SURGICAL AID

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

T2Candida 1.1 Panel

FDA 510(k)

FDA Class 2 ·Microbiology

APEX MODULAR ALUMINA FEMORAL HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

HEMOSIL FACTOR XII DEFICIENT PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS

FDA 510(k)

FDA Class 2 ·Cardiovascular