LightWalker Laser System Family

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)

FDA 510(k)

FDA Class 2 ·General Hospital

DUS R-50S (Urine Chemistry system)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite

FDA 510(k)

FDA Class 2 ·Dental

Plaxpot Multi Plasma

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Shina Syringe; Shina Safety Syringe

FDA 510(k)

FDA Class 2 ·General Hospital

DATAMEDIX PECGASYS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

LIFESPAN EPTFE VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

TETRAFLEX INTEGRALLY SUPPORTED PTFE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PREVIEW XT

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO EPTFE GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

HTS 220 CARDIAC MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular