Injectable Root Canal Bioceramic Sealer (i-MTA SP)

FDA 510(k)

FDA Class 2 ·Dental

Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY,UI06 IG,)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medical Diode Laser (Model: L2)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MERISTEEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Single-Use Flexible Cystoscope

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRIOCLEAR System

FDA 510(k)

FDA Class 2 ·Dental

Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))

FDA 510(k)

FDA Class 2 ·Cardiovascular

1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Globalcare Blood Pressure Monitor (GUS610)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)

FDA 510(k)

FDA Class 2 ·Radiology

Medical Diode Laser (M2-GK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Single-Use Flexible Rhinolaryngoscope

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)

FDA 510(k)

FDA Class 2 ·Dental

Medical Diode Laser (S1Pro)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))

FDA 510(k)

FDA Class 2 ·Radiology

MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)

FDA 510(k)

FDA Class 2 ·Neurology

IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery