Normandy VBR System

FDA 510(k)

FDA Class 2 ·Orthopedic

KNOW-RECIRC

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MICROTEK EQUIPMENT DRAPES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VAULT ALIF SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SPINAL USA VBR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY

FDA 510(k)

FDA Class 2 ·Cardiovascular

YSIO

FDA 510(k)

FDA Class 2 ·Radiology

ECLIPSE WITH AAA

FDA 510(k)

FDA Class 2 ·Radiology

TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771

FDA 510(k)

FDA Class 2 ·Hematology

EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EMIT II PLUS ECSTASY ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Emit II Plus Cocaine Metabolite Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

RPM RESPIRATORY GATING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

EMIT CAFFEINE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

FDA 510(k)

FDA Class 2 ·Microbiology