CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS

FDA 510(k)

FDA Class 2 ·Radiology

ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800

FDA 510(k)

FDA Class 2 ·Immunology

ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8

FDA 510(k)

FDA Class 2 ·Immunology

VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST

FDA 510(k)

FDA Class 2 ·Immunology

XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267

FDA 510(k)

FDA Class 2 ·Immunology

ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800

FDA 510(k)

FDA Class 2 ·Immunology

TAG-IT CYSTIC FIBROSIS KIT

FDA 510(k)

FDA Class 2 ·Immunology

TAG-IT CYSTIC FIBROSIS KIT

FDA 510(k)

FDA Class 2 ·Immunology

xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTR

FDA 510(k)

FDA Class 2 ·Immunology

xTAG Cystic Fibrosis 39 Kit v2

FDA 510(k)

FDA Class 2 ·Immunology

XTAG CF60 KIT V2

FDA 510(k)

FDA Class 2 ·Immunology

INPLEX CF MOLECULAR TEST

FDA 510(k)

FDA Class 2 ·Immunology

CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01

FDA 510(k)

FDA Class 2 ·Immunology

System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

FDA classification

FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·UBIS 5000 BONE SONOMETER

ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST

FDA 510(k)

FDA Class 2 ·Radiology

CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·OSTEOSPACE

TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA

FDA 510(k)

FDA Class 2 ·Radiology