Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM

PICOCLAMP

FDA 510(k)

FDA Class 2 ·Cardiovascular

Crownjun Nylon Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML

FDA 510(k)

FDA Class 2 ·General Hospital

CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS

FDA 510(k)

FDA Class 2 ·Radiology

HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL

FDA 510(k)

FDA Class 2 ·Radiology

HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)

FDA 510(k)

FDA Class 2 ·Neurology

VISION (NUCLEAR MEDICINE COMPUTER)

FDA 510(k)

FDA Class 2 ·Radiology

HammerTube System

FDA 510(k)

FDA Class 2 ·Orthopedic

CORDIS VENTRICULAR ANTECHAMBER (VA)

FDA 510(k)

FDA Class 2 ·Neurology

TITAN 3-D™ Wedge System

FDA 510(k)

FDA Class 2 ·Orthopedic

CORDIS SHARP-ENDED STYLET; BLUNT-ENDED STYLET; CYST PUNCTURE CATHETER

FDA 510(k)

FDA Class 2 ·Neurology

Monster Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P

FDA 510(k)

FDA Class 2 ·Anesthesiology

Monster BITE Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO ENVOY AND VISTA BRITE TIP

FDA 510(k)

FDA Class 2 ·Cardiovascular

Phantom Small Bone Intramedullary Nail System

FDA 510(k)

FDA Class 2 ·Orthopedic

JAWS(TM) Nitinol Staple System

FDA 510(k)

FDA Class 2 ·Orthopedic

CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS

FDA 510(k)

FDA Class 2 ·Radiology