XN CHECK BF

FDA 510(k)

FDA Class 2 ·Hematology

PARA TECH PLUS RETICS

FDA 510(k)

FDA Class 2 ·Hematology

CASCADE BATH, MODEL 6900

FDA 510(k)

FDA Class 2 ·Physical Medicine

SPORE STRIP

FDA 510(k)

FDA Class 2 ·General Hospital

XN CAL

FDA 510(k)

FDA Class 2 ·Hematology

HeartSee Cardiac P.E.T. Processing Software

FDA 510(k)

FDA Class 2 ·Radiology

PROCHEM EXT CHEMICAL INTEGRATOR

FDA 510(k)

FDA Class 2 ·General Hospital

XN CHECK

FDA 510(k)

FDA Class 2 ·Hematology

CD-CHEX CD 34

FDA 510(k)

FDA Class 2 ·Hematology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ACS TX 2000 VP CORONARY DILATATION CATHETER CAHTETERS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SPRINTER OVER THE WIRE (OTW) & SPRINTER MULTI-EXCHANGE (MX2) BALLOON DILATATION CATHETER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-FREE SUPRACLENS

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 81573

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·IPAFLUOROFOCON A AND B

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·BOSTON EQUALENS(ITAFLUOROFOCON A)/EQUALENS II(OPRIFOCON A)

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY TFC DEVICE AND RAY TFC UNITE DEVICE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CATHSCANNER ORACLE MICRO PTCA CATHETER FACT & ARC BALLOON CORONARY DILATATION CATHETER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator