MONACO RTP SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE

FDA 510(k)

FDA Class 2 ·Radiology

SOM 6VI (SURGICAL OPERATING MICROSCOPE)

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

EL DORADO 58

FDA 510(k)

FDA Class 2 ·Dental

THROMBOPLASTIN WITH CALCIUM

FDA 510(k)

FDA Class 2 ·Hematology

ADMIRA

FDA 510(k)

FDA Class 2 ·Dental

VITEK 2 GRAM POSITIVE DOXCYCLINE

FDA 510(k)

FDA Class 2 ·Microbiology

JUHN TYM-TAP

FDA 510(k)

FDA Class 1 ·Pathology

MALLINCKRODT SHILEY 15MM CAP

FDA 510(k)

FDA Class 2 ·Anesthesiology

VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES

FDA 510(k)

FDA Class 1 ·Microbiology

INQU

FDA 510(k)

FDA Class 2 ·Orthopedic

FIBRINOGEN CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

FIRMM

FDA 510(k)

FDA Class 2 ·Radiology

VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

JEDMED SPECTRUM ENT CABINET

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

ImagenSPECT

FDA 510(k)

FDA Class 2 ·Radiology

TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

ELLIK EVACUATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology