Single Use Guide Sheath Kit-401, K-402

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)

FDA 510(k)

FDA Class 2 ·Radiology

COLOR LCD MONITOR, MODEL RADIFORCE R12

FDA 510(k)

FDA Class 2 ·Radiology

Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

R2P SlenGuide

FDA 510(k)

FDA Class 2 ·Cardiovascular

Visera Elite II Video System Center, Visera Elite II Endoeye 3D

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Radifocus Optitorque Angiographic Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

High Flow Insufflation Unit (UHI-4)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

5 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510

FDA 510(k)

FDA Class 2 ·Radiology

COLOR LCD MONITOR, RADIFORCE, MODEL RX210

FDA 510(k)

FDA Class 2 ·Radiology

Rhino-Laryngo Fiberscope Olympus ENF-GP2

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Single Use Aspiration Needle

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Radifocus Glidewire Advantage Track

FDA 510(k)

FDA Class 2 ·Cardiovascular

Progreat

FDA 510(k)

FDA Class 2 ·Cardiovascular

Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Airway Mobilescope

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Disposable Balloon Catheter B5-2C

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LCD MONITOR, RADIFORCE G11, G31, G51

FDA 510(k)

FDA Class 2 ·Radiology