Pre-Filled Normal Saline Flush Syringe

FDA 510(k)

FDA Class 2 ·General Hospital

Saline, Vascular Access Flush

FDA classification

FDA Class 2 ·Saline, Vascular Access Flush

ASTOFLO

FDA 510(k)

FDA Class 2 ·Hematology

DENTORIUM CONVERTIBLE ACRYLIC

FDA 510(k)

FDA Class 2 ·Dental

MONORAIL

FDA 510(k)

FDA Class 2 ·Dental

BF-NAVI

FDA 510(k)

FDA Class 2 ·Radiology

HYDROTONE-THERMAL CAPSULE SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

POWERED WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

XENON DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CIMILRE Free-T2 Plus

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CARDIO-VIEW

FDA 510(k)

FDA Class 2 ·Cardiovascular

MULTI-MODALITY IMAGE FUSION

FDA 510(k)

FDA Class 2 ·Radiology

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius System 100 and GI Genius System 200

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GI Genius

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PEAK FLOWMETERS FOR SPIROMETRY

FDA 510(k)

FDA Class 2 ·Anesthesiology

UNI-TENS XL TENS

FDA 510(k)

FDA Class 2 ·Neurology

AGAR 9K TENS

FDA 510(k)

FDA Class 2 ·Neurology