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

FDA Pre-Market Approval

FDA Class 2 ·COBAS® TaqMan® HCV Test, v2.0, for Use with the High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test, v2.0

I-125 SEEDS, CODE: 6711

FDA 510(k)

FDA Class 2 ·Radiology

Apyx Plasma/RF Handpiece

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SREE MRI Transport Incubator

FDA 510(k)

FDA Class 2 ·General Hospital

ECHOSEED/IODINE-125 SEEDS, MODEL 6733

FDA 510(k)

FDA Class 2 ·Radiology

SMART LABEL, PROPOFOL

FDA 510(k)

FDA Class 2 ·General Hospital

Flexitouch Plus System

FDA 510(k)

FDA Class 2 ·Cardiovascular

FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Tecomet Global Unite Short Stem Instrumentation

FDA 510(k)

FDA Class 2 ·Orthopedic

AccuPoint Electrode

FDA 510(k)

FDA Class 2 ·Neurology

I-125 SEEDS IN CARRIER, CODE: 6720

FDA 510(k)

FDA Class 2 ·Radiology

Premier Resolution System

FDA 510(k)

FDA Class 2 ·Hematology

REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION

FDA 510(k)

FDA Class 2 ·Orthopedic

INNER PEACE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

Flexitouch System

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRESAGE ST2 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Clio Prime and Clio Pedo

FDA 510(k)

FDA Class 2 ·Dental

E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER

FDA 510(k)

FDA Class 2 ·Cardiovascular