Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCIMED ACE(TM) & LONG ACE(TM) PTCA CATHETERS

ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

YSIO

FDA 510(k)

FDA Class 2 ·Radiology

TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Mosaic (V1.0.1)

FDA 510(k)

FDA Class 2 ·Radiology

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,

FDA 510(k)

FDA Class 2 ·Microbiology

LITHOSKOP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ARTIS ZEE AND ZEEGO

FDA 510(k)

FDA Class 2 ·Radiology

ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

GMI Frontier Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

VENUS BASIC SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACE BEADED K-WIRES ACE OLIVE WIRES

FDA 510(k)

FDA Class 2 ·Orthopedic

ACE Cannula

FDA 510(k)

FDA Class 2 ·General Hospital

VELO ACE

FDA 510(k)

FDA Class 2 ·Radiology

ACE VERSANAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

ACE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACE AND ACE/FISCHER PRE-DRILL PIN SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Automatic Continuous Effusion Shunt (ACES) System ACES System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology