WELLCOGEN BACTERIAL ANTIGEN KIT

FDA 510(k)

FDA Class 2 ·Microbiology

FREEDOM CONSTRAINED LINERS

FDA 510(k)

FDA Class 2 ·Orthopedic

WILLCOGEN MENINGITIDIS KIT ZL25

FDA 510(k)

FDA Class 2 ·Microbiology

35/CD CINECONVERTER

FDA 510(k)

FDA Class 2 ·Radiology

MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51

FDA 510(k)

FDA Class 2 ·Microbiology

WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24

FDA 510(k)

FDA Class 2 ·Microbiology

FENCER 308 EXCIMER LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

BD PEN NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)

FDA 510(k)

FDA Class 2 ·Microbiology

BD VACUTAINER PLUS PST II TUBE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml

FDA 510(k)

FDA Class 2 ·Microbiology

PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

BD PEN NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258

FDA 510(k)

FDA Class 2 ·Clinical Chemistry