MICRUS MICROCOIL SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

EMIT(R) II BENZODIAZEPINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CYTOVISION FOR CEP XY

FDA 510(k)

FDA Class 2 ·Immunology

Aveta System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SYVA EMIT II PROPOXYPHENE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URETERAL BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

LASERSCOPE AUTOMATIC EYE PROTECTION FILTER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GUIDING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS

FDA 510(k)

FDA Class 2 ·Hematology

SDC3 HD Information Management System with Wireless Device Control Capability

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES

FDA 510(k)

FDA Class 2 ·Hematology

BD FACSCANTO SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

EMIT(R) IIC OPIATE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

FDA 510(k)

FDA Class 2 ·Microbiology

VitalConnect Platform, VitalPatch Biosensor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Invisalign System

FDA 510(k)

FDA Class 2 ·Dental

EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229

FDA 510(k)

FDA Class 2 ·Clinical Toxicology