Materialise PKA Guide System

FDA 510(k)

FDA Class 2 ·Orthopedic

Partial Knee Application (PKA)

FDA 510(k)

FDA Class 2 ·Neurology

Materialise PKA Guide System

FDA 510(k)

FDA Class 2 ·Orthopedic

Materialise PKA Guide System

FDA 510(k)

FDA Class 2 ·Orthopedic

RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Reza Band, Reflux Band

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

External Upper Esophageal Sphincter (Ues) Compression Device

FDA classification

FDA Class 2 ·External Upper Esophageal Sphincter (Ues) Compression Device

T1040 AKA AURAWAVE

FDA 510(k)

FDA Class 2 ·Neurology

Leone Orthodontic Implant TAD (Temporary Anchorage Device)

FDA 510(k)

FDA Class 2 ·Dental

Implant, Endosseous, Root-Form

FDA Pre-Market Approval

FDA Class 2 ·AUGMEN(TM) AKA SYNTHOGRAFT(TM) LG

Vario-Cup System

FDA 510(k)

FDA Class 2 ·Orthopedic

Samsung ECG App v 1.3 (ECG)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ESTEMP IMPLANT, ESTEMP CLEAR

FDA 510(k)

FDA Class 2 ·Dental

BASE IT

FDA 510(k)

FDA Class 2 ·Dental

Sleep Apnea Feature

FDA 510(k)

FDA Class 2 ·Anesthesiology

Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

FDA 510(k)

FDA Class 2 ·Cardiovascular

LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface

FDA 510(k)

FDA Class 2 ·Orthopedic

SP-CL Hip Stem and LCU Hip System

FDA 510(k)

FDA Class 2 ·Orthopedic

MULTI-PRIME AKA/MONO-PRIME

FDA 510(k)

FDA Class 2 ·Dental