Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·PAPNET (R) TESTING SYSTEM

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·AUTOPAP SYSTEM

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis product family abd GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis product family abd GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family

BD Surgiphor™ Antimicrobial Irrigation System

FDA 510(k)

FDA Class 2 ·General Hospital

BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757

FDA 510(k)

FDA Class 2 ·General Hospital

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

BD SPRING BASED SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD INTEGRA SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit

FDA 510(k)

FDA Class 2 ·Microbiology

0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS

FDA 510(k)

FDA Class 1 ·Microbiology

INTERLINK THREADED LOCK CANNULA

FDA 510(k)

FDA Class 2 ·General Hospital

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

FDA 510(k)

FDA Class 2 ·Microbiology

BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET

FDA 510(k)

FDA Class 2 ·General Hospital

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM MODEL 7227 CX/B/D/E