XENON DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CIMILRE Free-T2 Plus

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)

FDA 510(k)

FDA Class 2 ·Dental

Female IC (Not Finalized)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Intermittent Catheter (Not Finalized)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ORTHO-1(NOT FINALIZED)

FDA 510(k)

FDA Class 2 ·Dental

ORTHODONTIC ACRYLIC (NOT FINALIZED)

FDA 510(k)

FDA Class 2 ·Dental

Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

IV Sets not made with PVC

FDA 510(k)

FDA Class 2 ·General Hospital

ALL-BOND UNIVERSAL SC (NOT FINALIZED)

FDA 510(k)

FDA Class 2 ·Dental

All-Bond Universal w/BAC (not finalized)

FDA 510(k)

FDA Class 2 ·Dental

SCANSCOPE XT SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

VIRTUSO SYSTEM FOR IHC (DO-7)

FDA 510(k)

FDA Class 2 ·Hematology

SCANSCOPE XT SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU

FDA 510(k)

FDA Class 2 ·Hematology

APERIO EPATHOLOGY EIHC IVD SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)

FDA 510(k)

FDA Class 2 ·Hematology

VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)

FDA 510(k)

FDA Class 2 ·Hematology

VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)

FDA 510(k)

FDA Class 2 ·Hematology

ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

FDA 510(k)

FDA Class 2 ·Hematology