LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·BAK INTERBODY FUSION SYSTEM, BP/LORDOTIC DEVICE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY

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

FDA 510(k)

FDA Class 2 ·General Hospital

Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE)

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

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

MED-RX EXTENSION SETS

FDA 510(k)

FDA Class 2 ·General Hospital

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

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

VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery