AA temp temporary restoration 3D printing photoreactive resin

FDA 510(k)

FDA Class 2 ·Dental

Ceramic Bracket

FDA 510(k)

FDA Class 2 ·Dental

EFAI PACS Picture Archiving and Communication System

FDA 510(k)

FDA Class 2 ·Radiology

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System

FDA 510(k)

FDA Class 2 ·Radiology

DailyMate Orthodontic Aligner System

FDA 510(k)

FDA Class 2 ·Dental

EFAI RTSuite CT HN-Segmentation System

FDA 510(k)

FDA Class 2 ·Radiology

EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)

FDA 510(k)

FDA Class 2 ·Radiology

EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)

FDA 510(k)

FDA Class 2 ·Radiology

New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Arm Type Blood Pressure Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

EpiFaith Syringe

FDA 510(k)

FDA Class 2 ·General Hospital

BU-CAD

FDA 510(k)

FDA Class 2 ·Radiology

HYPNOSPAD

FDA 510(k)

FDA Class 2 ·Dental

SperSort™ Sperm Sorting Chip (IPG02)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)

FDA 510(k)

FDA Class 2 ·Radiology

MEM Clear Aligner System

FDA 510(k)

FDA Class 2 ·Dental

Apache Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

RIA Safeguard

FDA 510(k)

FDA Class 2 ·General Hospital

ORION Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)

FDA 510(k)

FDA Class 2 ·Physical Medicine