Quell-FM

FDA 510(k)

FDA Class 2 ·Neurology

BIOPLEX VASCULITIS KIT

FDA 510(k)

FDA Class 2 ·Immunology

AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ATHENA MULTI-LYTE GBM TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

PRECLUDE IMA SLEEVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

GORE PRECLUDE VESSEL GUARD

FDA 510(k)

FDA Class 2 ·Cardiovascular

EMIT DIGOXIN MOBILE PHASE SOLUTION

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EYECLOSE EXTERNAL EYELID WEIGHTS

FDA 510(k)

FDA Class 2 ·Ophthalmic

Varian Head Frame

FDA 510(k)

FDA Class 2 ·Radiology

EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HTx Disposable Hysteroscope System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Respiratory Gating for Scanners

FDA 510(k)

FDA Class 2 ·Radiology

Sonu

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

INFUSASLEEVE IIA (IS-2A)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING

FDA 510(k)

FDA Class 2 ·Radiology

VARIAN RADIATION THERAPY IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90

FDA 510(k)

FDA Class 2 ·Radiology

EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ALEXIS

FDA 510(k)

FDA Class 2 ·Physical Medicine