PMMA CAD/CAM DISC

FDA 510(k)

FDA Class 2 ·Dental

FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Tosama 100% Cotton Menstrual Tampon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5

FDA 510(k)

FDA Class 2 ·Radiology

XIDF-AWS801, Angio Workstation, V7.0

FDA 510(k)

FDA Class 2 ·Radiology

Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0

FDA 510(k)

FDA Class 2 ·Radiology

Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

Applanation tonometer AT-2

FDA 510(k)

FDA Class 2 ·Ophthalmic

Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Serve (TSX-307A/1) V1.3

FDA 510(k)

FDA Class 2 ·Radiology

EVIS EXERA III Bronchovideoscope Olympus BF-XT190

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Xario 200 Diagnostic Ultrasound System V6.0

FDA 510(k)

FDA Class 2 ·Radiology

Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Thunderbeat Open Fine Jaw Type X Hand Instrument

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aquilion Precision (TSX-304A/4) V10.14 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

Konicaminolta DI-X1

FDA 510(k)

FDA Class 2 ·Radiology