GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRISMAFLEX SYSTEM 7.10

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRISMAFLEX M150 SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

V5med Lung AI

FDA 510(k)

FDA Class 2 ·Radiology

ORTHOCOR KNEE SYSTEM BASIC

FDA 510(k)

FDA Class 2 ·Physical Medicine

LEGACY3 6MM LENGTH IMPLANTS

FDA 510(k)

FDA Class 2 ·Dental

INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

VENOTRAIN CURAFLOW

FDA 510(k)

FDA Class 2 ·General Hospital

REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EpiFaith Syringe

FDA 510(k)

FDA Class 2 ·General Hospital

BIOTEQ Drainage Catheter Set (One Step Type)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology