BEBIG PLAQUES RUM101-RUM114

FDA 510(k)

FDA Class 2 ·Radiology

WAKO AUTOKIT LP(A)/ RA,500/1000,

FDA 510(k)

FDA Class 2 ·Immunology

ACCLARENT AERA Eustachian Tube Balloon Dilation System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Acclarent Aera Eustachian Tube Balloon Dilation System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A

FDA 510(k)

FDA Class 2 ·Radiology

Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit

FDA 510(k)

FDA Class 2 ·Radiology

PREMIER BLASTOMYCES

FDA 510(k)

FDA Class 2 ·Microbiology

POREX(TM) EAR PROSTHESIS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CANAL WALL PROSTHESIS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EPIDURAL CATHETER TRAY

FDA 510(k)

FDA Class 2 ·Microbiology

ePTFE-Coated Auricular Implant

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ATTIC DEFECT PLATE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT

FDA 510(k)

FDA Class 2 ·Cardiovascular

J.B.S. ANTERIOR SPINE SYSTEM(R)

FDA 510(k)

FDA Class 2 ·Orthopedic

MAXIMA PLUS HOLLOW FIBER OXYGENATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.

FDA 510(k)

FDA Class 2 ·Cardiovascular

MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFIED INTERSEPT PEDIATRIC BLOOD FILTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTERSEPT* OXYGEN GAS LINE FILTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC ARTERIAL FILTER

FDA 510(k)

FDA Class 2 ·Cardiovascular