Indy OTW Vascular Retriever

FDA 510(k)

FDA Class 2 ·Cardiovascular

LiquID .051 LP Guide Catheter Extension

FDA 510(k)

FDA Class 2 ·Cardiovascular

BPBIO750

FDA 510(k)

FDA Class 2 ·Cardiovascular

Coda LP Balloon Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MIS Bunion System

FDA 510(k)

FDA Class 2 ·Orthopedic

MEDICAL SUPPORT STOCKINGS 2001/2002

FDA 510(k)

FDA Class 2 ·General Hospital

MIS Bunion Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

Conical Plus Implant System

FDA 510(k)

FDA Class 2 ·Dental

CrossRoads Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK DIGITAL

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY

Tek RMD (Tek Robotic Mobilization Device)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.0

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·PowerLook® Tomo Detection Software

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

VENUS CERVICAL SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

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

SIMDA abutment

FDA 510(k)

FDA Class 2 ·Dental