Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER MODELS HM3 AND HM4

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER MODELS HM3 AND HM4

Laser Therapy Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Intra medullary endo-transilluminating device (iMET device)

FDA 510(k)

FDA Class 2 ·Orthopedic

CERALAS G ND;YAG LASER SYSTEM (CERALAS G)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Mjolnir Pro. (Multi–electrode plasma)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LED Therapy Device (Planar LED/Planar LED mini)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Planar LED mate

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

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

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

Leaf Smooth

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)

FDA 510(k)

FDA Class 2 ·Orthopedic

EFAI ChestSuite XR Pleural Effusion Assessment System

FDA 510(k)

FDA Class 2 ·Radiology

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

Ventway Sparrow

FDA 510(k)

FDA Class 2 ·Anesthesiology

HM-RUBY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery