NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BONART ART-L2 LIGHT CURING UNIT

FDA 510(k)

FDA Class 2 ·Dental

BONART ART-L5 LED CORDLESS CURING LIGHT

FDA 510(k)

FDA Class 2 ·Dental

ASSERACHROM PF4 KIT

FDA 510(k)

FDA Class 2 ·Hematology

SHASER V-MINI 2 HAIR REMOVAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMBIENT TURBOFLASH 90 IFS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TITAN DYSPLASIC TOTAL HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TITAN TROCHANTERO-DIAHYSEAL TOTAL HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER

FDA 510(k)

FDA Class 2 ·Orthopedic

SHASER HRS2 RX HAIR REMOVAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SHASER V-MINI HAIR REMOVAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MORPHOMETRIC TOTAL HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

EUROFORM TOTAL HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·DTU-ONE ULTRASOUND SCANNER

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT CEA-EIA ONE-STEP

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·OPTI-ONE(R) MULTI-PURPOSE SOLUTION