Electric Breast Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor

FDA 510(k)

FDA Class 2 ·Radiology

IPL Hair Removal Device (KCA511/KCA516/KCA522)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Leltek Ultrasound Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

SysMed S/T

FDA 510(k)

FDA Class 2 ·Anesthesiology

Diode laser system (Night Universe; Predator)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Muscle Stimulator Device (PZ-100)

FDA 510(k)

FDA Class 2 ·Physical Medicine

MedalOne Total Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

Leltek Ultrasound Imaging System (Model: LU700 Series)

FDA 510(k)

FDA Class 2 ·Radiology

BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank

FDA 510(k)

FDA Class 2 ·Dental

Electronic Sphygmomanometer (Model: LT-P30)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Fingertip Pulse Oximeter

FDA 510(k)

FDA Class 2 ·Cardiovascular

JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor

FDA 510(k)

FDA Class 2 ·Radiology

Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging

FDA 510(k)

FDA Class 2 ·Radiology

Oxygen Concentrator

FDA 510(k)

FDA Class 2 ·Anesthesiology

UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Diode Laser Therapy Device (DF-DIODE LASER-S1)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery