Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE-EASE MODEL 3500

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·D114S OTW BALLOON DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·POWERSAIL(TM)/HIGHSAIL(TM) CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED NC MAXXUM PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Pulse Generator, External Pacemaker, Dual Chamber

FDA Pre-Market Approval

FDA Class 2 ·REOCOR S / D FAMILY OF EXTERNAL PACEMAKERS

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER COMPACT DELTA

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·BOSTON SCIENTIFIC SCIMED MAVERICK(TM) OVER-THE-WIRE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED MAVERICK(TM) MONORAIL(TM) (PTCA) CATHETER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ICAD SYSTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·COMPLETE BRAND LUBRICATING AND REWETTING DROPS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·GOLDIE TM AND GOLDIE TM LONGY PTCA CATHETERS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Elecsys Anti-HCV II

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·HOLOGIC SAHARA CLINICAL BONE SONOMETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORONARY FLEXTOME CUTTING BALLOON

Glucose Oxidase, Glucose

FDA Pre-Market Approval

FDA Class 2 ·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheter, Flow Directed

FDA Pre-Market Approval

FDA Class 2 ·ESPRIT/CROSSAIL/OPENSAIL/POWERSAIL/HIGHSAIL CORONARY DILATION CATHETHERS