Valkyrie Thoracic Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems

FDA 510(k)

FDA Class 2 ·Medical Genetics

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

OsOpia Synthetic Bone Void Filler

FDA 510(k)

FDA Class 2 ·Dental

Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

FDA classification

FDA Class 2 ·Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Infant Supine Sleep System

FDA classification

FDA Class 2 ·Infant Supine Sleep System

Control Material, Blood Circulating Epithelial Cancer Cell

FDA classification

FDA Class 2 ·Control Material, Blood Circulating Epithelial Cancer Cell

Media, Reproductive, Exempt

FDA classification

FDA Class 2 ·Media, Reproductive, Exempt

Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

FDA classification

FDA Class 2 ·Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers