FIBRI-PREST/THROMBIN-PREST CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology

STACHROM ANTIPLASMIN CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

POREX(TM) NOSE PROSTHESIS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT

FDA 510(k)

FDA Class 2 ·Ophthalmic

CENTERPIECE PLATE FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE

FDA 510(k)

FDA Class 2 ·Cardiovascular

VISTA MR 2055 HP SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

POROSTEON PHUSION METAL CERVICAL CAGE

FDA 510(k)

FDA Class 2 ·Orthopedic

APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST

FDA 510(k)

FDA Class 2 ·Microbiology

8810 PUMP-PUMP SINGLE NEEDLE DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ORTHO* SYPHILIS-M ANTIBODY ELISA TEST

FDA 510(k)

FDA Class 2 ·Microbiology

STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ASSERA-PLATE PROTEIN C KIT

FDA 510(k)

FDA Class 2 ·Hematology

COAGULATION CONTROL, LEVEL I

FDA 510(k)

FDA Class 2 ·Hematology

VISTA HPQ SYSTEM, VISTA MR 2055 HP SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

DETECTADOT SYSTEM 2000 HETEROPHILE TEST

FDA 510(k)

FDA Class 2 ·Immunology

CD HORIZON SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFIED D-DI-TEST KIT

FDA 510(k)

FDA Class 2 ·Hematology