JTK Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

uMR Omega with uWS-MR-MRS

FDA 510(k)

FDA Class 2 ·Radiology

Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Micro-current Wrinkle Reduction Facial service, model EP-400

FDA 510(k)

FDA Class 2 ·Neurology

easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Focus 43C detector, TRIMAX 43C detector

FDA 510(k)

FDA Class 2 ·Radiology

Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Dawn Diode Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Kingon P2 Oxygen Concentrator

FDA 510(k)

FDA Class 2 ·Anesthesiology

KD-622 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

TENS & PMS Unit

FDA 510(k)

FDA Class 2 ·Neurology

Disposable Insulin Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

GIA Stapler with Tri-Staple Technology

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Finger Pulse Oximeter, Model: X1906P

FDA 510(k)

FDA Class 2 ·Cardiovascular

Arm-type Fully Automatic Digital Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

OEC One ASD

FDA 510(k)

FDA Class 2 ·Radiology

Steam Sterilizer (2545D)

FDA 510(k)

FDA Class 2 ·General Hospital