KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

FDA 510(k)

FDA Class 2 ·Immunology

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

FDA 510(k)

FDA Class 2 ·Immunology

KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

Tyrosine Phosphatase (Ia-2) Autoantibody Assay

FDA classification

FDA Class 2 ·Tyrosine Phosphatase (Ia-2) Autoantibody Assay

HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS

FDA 510(k)

FDA Class 2 ·Immunology

ACROSSPINE PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

HEMODIALYSIS TUBING SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·SGP II - F CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·SGP II - F CONTACT LENS

LIF-O-GEN #3000 OXYGEN CONCENTRATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Pirouette 014

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRUSELECT Microcatheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Emerge Monorail PTCA Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pirouette 035

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016

FDA 510(k)

FDA Class 2 ·Dental

SAFE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MEDSYNAPSE Zero Footprint Viewer

FDA 510(k)

FDA Class 2 ·Radiology

Medsynapse Ris Pacs & Medsynapse VNA

FDA 510(k)

FDA Class 2 ·Radiology