GETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD

Elecsys AMH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys TSH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable

FDA 510(k)

FDA Class 2 ·Cardiovascular

Elecsys Tg II

FDA 510(k)

FDA Class 2 ·Immunology

Q Guidance System; Mako Spine System;

FDA 510(k)

FDA Class 2 ·Neurology

ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MitraClip G4 Steerable Guide Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment

FDA 510(k)

FDA Class 2 ·Orthopedic

Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT

FDA 510(k)

FDA Class 2 ·Immunology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK (SL) CAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER CAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·MAMMOGRAPHY CAD ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK (SL) CAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·KODAK MAMMOGRAPHY CAD ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·KODAK MAMMOGRAPHY CAD ENGINE