ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORION DIAGNOSTICA ULTRASENSITIVE CRP CONTROL, MODEL 68257

FDA 510(k)

FDA Class 2 ·Immunology

Orthopantomograph™ OP 3D LX

FDA 510(k)

FDA Class 2 ·Radiology

DIGORA OPTIME (OR DIGORA ONTIME)

FDA 510(k)

FDA Class 2 ·Dental

BonAlive Granules

FDA 510(k)

FDA Class 2 ·Orthopedic

HAAG-STREIT FUNDUS MODULE 300

FDA 510(k)

FDA Class 2 ·Ophthalmic

AS/3 PRESSURE TEMPERATURE MODULE, M-PT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nexstim Navigated Brain Therapy (NBT) System 2

FDA 510(k)

FDA Class 2 ·Neurology

DELTA 16

FDA 510(k)

FDA Class 2 ·Radiology

THERMOFX MESH

FDA 510(k)

FDA Class 2 ·Dental

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR

Ceruloplasmin, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Ceruloplasmin, Fitc, Antigen, Antiserum, Control

Analyzer, Gas, Nitrogen, Gaseous-Phase

FDA classification

FDA Class 2 ·Analyzer, Gas, Nitrogen, Gaseous-Phase

Endoscopic Magnetic Retriever, Exempt

FDA classification

FDA Class 2 ·Endoscopic Magnetic Retriever, Exempt