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

BowTie™ SI Joint Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

DISTAL RADIO-ULNAR JOINT IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

Cranial COVER

FDA 510(k)

FDA Class 2 ·Neurology

Neuronaute with IceCap 2 & IceCap 2 Small

FDA 510(k)

FDA Class 2 ·Neurology

Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

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

FDA 510(k)

FDA Class 2 ·Medical Genetics

SMR Reverse HP Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

Nerve Capping Device

FDA 510(k)

FDA Class 2 ·Neurology

NEUROLAC(R) NERVE GUIDE

FDA 510(k)

FDA Class 2 ·Neurology

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

Evie Med Ring

FDA 510(k)

FDA Class 2 ·Cardiovascular