Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK DIGITAL V7.2 CAD

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

FDA 510(k)

FDA Class 2 ·General Hospital

EARLOOP FACE MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Apache Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Helianthus

FDA 510(k)

FDA Class 2 ·Radiology

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

Surgical Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS

FDA 510(k)

FDA Class 2 ·Cardiovascular

PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK (SL) CAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·MAMMOGRAPHY CAD ENGINE

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

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

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·KODAK MAMMOGRAPHY CAD ENGINE

Electric Wheelchair

FDA 510(k)

FDA Class 2 ·Physical Medicine

Aglaia LED Beauty Device (BP-D2309)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CLINICAL ELECTRONIC THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital