STARCERAM

FDA 510(k)

FDA Class 2 ·Dental

StarCeram® Z-Nature, StarCeram® Z-Smile

FDA 510(k)

FDA Class 2 ·Dental

Blood Collection Accessory (BUCA)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Bevel Up Holder

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Blood Transfer Accessory (BTA)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SafetiCET Safety Lancet

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SafetiHeel, MediHeel, Novaplus

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PROView

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·RAPTORAIL PTCA DILATATION CATHETER (RX)

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST

BEST PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DENSICOMP 250

FDA 510(k)

FDA Class 2 ·Radiology

STARCERAM

FDA 510(k)

FDA Class 2 ·Dental

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX(R) HAVAB(R)-M

KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)

FDA 510(k)

FDA Class 2 ·Radiology

Efficient Care 3D Planning

FDA 510(k)

FDA Class 2 ·Radiology

iASSIST Knee System

FDA 510(k)

FDA Class 2 ·Neurology

ROSA Hip System

FDA 510(k)

FDA Class 2 ·Radiology