SPIRIT, MODEL HAS

FDA 510(k)

FDA Class 2 ·Anesthesiology

3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology

FDA 510(k)

FDA Class 2 ·General Hospital

BD Centro Vena Acute Central Line (7 French Dual Lumen)

FDA 510(k)

FDA Class 2 ·General Hospital

BD Acute Central Line

FDA 510(k)

FDA Class 2 ·General Hospital

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETER

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK/CERVICAL (BAK/C) (R) INTERBODY FUSION SYSTEM

Pulse-Generator, Pacemaker, External

FDA Pre-Market Approval

FDA Class 2 ·MICRO-PACE MODEL 4580 DUAL-CHAMBER,DDD,TEMPORARY CARDIAC PACEMAKER

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK/PROXIMITY(TM) INTERBODY FUSION SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·OSTEOBOND(TM) COPOLYMER BONE CEMENT

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK (TM)

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·KODAK MAMMOGRAPHY CAD ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·RAPIDSCREEN RS-2000

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·DERMABOND TOPICAL SKIN ADHESIVE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK/C VISTA CERVICAL INTERBODY FUSION DEVICE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER (CAD) SYSTEM, M1000

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ONGUARD