Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·INTER FIX THREADED FUSION DEVICE, INTER FIX RP THREADED FUSION DEVICE AND LT-CAGE LUMBAR TAPERED FUSION DEVICE

SIRIO H3

FDA 510(k)

FDA Class 2 ·Radiology

SleepImage System

FDA 510(k)

FDA Class 2 ·Anesthesiology

GOLNIT Non-Absorbable PTFE Surgical Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cortex Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MULTI-MODALITY IMAGE FUSION

FDA 510(k)

FDA Class 2 ·Radiology

COMPASS COMPRESSION ASSIST HANDLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Personalized Physiology Analytics Engine software

FDA 510(k)

FDA Class 2 ·Cardiovascular

UltraEzAir® (UEA1A)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Alio Medical Remote Monitoring System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Kuvia3D

FDA 510(k)

FDA Class 2 ·Radiology

EPIFLO-28

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SleepImage System

FDA 510(k)

FDA Class 2 ·Anesthesiology

Phoenix

FDA 510(k)

FDA Class 2 ·Physical Medicine

TRANQUILL BARBED DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Trinity Plus Wrinkle Reducer

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ruthless Spine RJB

FDA 510(k)

FDA Class 2 ·Orthopedic

Lorals

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology