Hemolung Respiratory Assist System

FDA 510(k)

FDA Class 2 ·Cardiovascular

GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION

FDA 510(k)

FDA Class 2 ·Anesthesiology

TSRH SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PRO-GUIDE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PARA-CARE

FDA 510(k)

FDA Class 2 ·Physical Medicine

ACON BUP ONE STEP BUPRENORPHINE TEST STRIP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

HEALTHBUDDY WITH DEVICE CONNECT [GLUCOSE METER]

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FLOWLINE BIOPORE EPTFE VASCULAR GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems

FDA 510(k)

FDA Class 2 ·Orthopedic

DIVERGENCE-L Anterior/Oblique Lumbar Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

Elite Nitinol Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

MARS HOLTER ANALYSIS WORKSTATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

Solevy Co. LLC Water-Based Personal Lubricant

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NPAC

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

A’TOMIC™ Nitinol Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Speed, Speed Shift, Speed Titan, Speed Arc

FDA 510(k)

FDA Class 2 ·Orthopedic

UNiTi ACDF Implant System

FDA 510(k)

FDA Class 2 ·Orthopedic

EPICARIDA, LE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPECTROPAD SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine