ZIRACE

FDA 510(k)

FDA Class 2 ·Dental

IGI-SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

HemoScreen Hematology Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

Disposable Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ESOP S/C FEMORAL STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CABOCHON SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ATLAS III ACETABULAR CUP

FDA 510(k)

FDA Class 2 ·Orthopedic

MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CHILI PACS

FDA 510(k)

FDA Class 2 ·Radiology

MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

FXA (TM)

FDA 510(k)

FDA Class 2 ·Radiology

MAHE FIXATION PLATE AND SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC

FDA 510(k)

FDA Class 2 ·Cardiovascular

PSM LOMAS / BENEFIT SCREWS

FDA 510(k)

FDA Class 2 ·Dental

Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098

FDA 510(k)

FDA Class 2 ·Anesthesiology

ERGOSELECT 100 K/P, ERGOSELECT 200 K/P

FDA 510(k)

FDA Class 2 ·Physical Medicine

STIMUPLEX PEN

FDA 510(k)

FDA Class 2 ·Anesthesiology

STIMUPLEX HNS-12, MODEL 4892098

FDA 510(k)

FDA Class 2 ·Anesthesiology