Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER 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 ·SECONDLOOK DIGITAL

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY

BcSs-PICNI-2000 Sensor

FDA 510(k)

FDA Class 2 ·Neurology

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

FDA 510(k)

FDA Class 2 ·General Hospital

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

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

FDA 510(k)

FDA Class 2 ·General Hospital

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

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

SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FMT Disposable and Autoclavable Temperature Probes

FDA 510(k)

FDA Class 2 ·General Hospital

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER D

STARLITE-OM, LIGHT EFFECTS, THIBIANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)

FDA 510(k)

FDA Class 2 ·General Hospital

FMT Reusable Temperature Probes

FDA 510(k)

FDA Class 2 ·General Hospital

GYRUS ENDOUROLOGY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology