SPIFE URINE IFE

FDA 510(k)

FDA Class 2 ·Immunology

BOEHRINGER MANNHEIM IGM ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET

FDA 510(k)

FDA Class 2 ·General Hospital

Ebony PTA 0.035 Peripheral Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony HP PTA OTW 0.035 Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Amethyst HP PTA OTW 0.035 Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony PTA .014 RX Pheripheral Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Tamarin Blue PTCA RX Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ebony PTA 0.014 RX Peripheral Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ICT

FDA 510(k)

FDA Class 2 ·Radiology

VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T

FDA 510(k)

FDA Class 2 ·Radiology

HyPHo Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)

FDA 510(k)

FDA Class 2 ·Neurology

IMRIS ONCOLOGY PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

Microdent Sterilization Cassette

FDA 510(k)

FDA Class 2 ·General Hospital

Kuros TLIF Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

MagnetOs

FDA 510(k)

FDA Class 2 ·Orthopedic

MagnetOs granules

FDA 510(k)

FDA Class 2 ·Orthopedic

AttraX Putty

FDA 510(k)

FDA Class 2 ·Orthopedic