Patient Positioning Devices

FDA 510(k)

FDA Class 2 ·Radiology

RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Patient Monitor, models LM-8, LM-10, LM-12 and LM-15

FDA 510(k)

FDA Class 2 ·Cardiovascular

LE-12CH

FDA 510(k)

FDA Class 2 ·Cardiovascular

Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17

FDA 510(k)

FDA Class 2 ·Cardiovascular

NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System

FDA 510(k)

FDA Class 2 ·Orthopedic

INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine

Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator

FDA 510(k)

FDA Class 2 ·Neurology

PlaniMax Orthodontic Software

FDA 510(k)

FDA Class 2 ·Dental

Ortho Solutions Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUANTASE PHE/GAL SCREENING ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Volition Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams

FDA 510(k)

FDA Class 2 ·Orthopedic

BP 5000

FDA 510(k)

FDA Class 2 ·Cardiovascular

C50 and C80 Multi-parameter Patient Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

Duet External Drainage and Monitoring System (EDMS)

FDA 510(k)

FDA Class 2 ·Neurology

Medtronic DUET External Drainage and Monitoring System

FDA 510(k)

FDA Class 2 ·Neurology