Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN

Computerized Cognitive Assessment Aid For Concussion

FDA classification

FDA Class 2 ·Computerized Cognitive Assessment Aid For Concussion

Chest X-Ray Computer Aided Detection

FDA classification

FDA Class 2 ·Chest X-Ray Computer Aided Detection

Hearing Aid, Air Conduction, Transcutaneous System

FDA classification

FDA Class 2 ·Hearing Aid, Air Conduction, Transcutaneous System

Tympanic Membrane Direct Contact Hearing Aid

FDA classification

FDA Class 2 ·Tympanic Membrane Direct Contact Hearing Aid

Hearing Aid, Group And Auditory Trainer

FDA classification

FDA Class 2 ·Hearing Aid, Group And Auditory Trainer

Cpr Aid Feedback Device (No Software)

FDA classification

FDA Class 2 ·Cpr Aid Feedback Device (No Software)

Pediatric Autism Spectrum Disorder Diagnosis Aid

FDA classification

FDA Class 2 ·Pediatric Autism Spectrum Disorder Diagnosis Aid

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·COBAS CMV

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME CMV

Access PCT

FDA 510(k)

FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS HCV TEST

Colon Computed Tomography System, Computer Aided Detection

FDA classification

FDA Class 2 ·Colon Computed Tomography System, Computer Aided Detection

Calibrator, Hearing Aid / Earphone And Analysis Systems

FDA classification

FDA Class 2 ·Calibrator, Hearing Aid / Earphone And Analysis Systems

Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

FDA classification

FDA Class 2 ·Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Lung Computed Tomography System, Computer-Aided Detection

FDA classification

FDA Class 2 ·Lung Computed Tomography System, Computer-Aided Detection

Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

FDA classification

FDA Class 2 ·Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid