Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS

I.V. ADMINISTRATION SET CONNECTING DEVICE

FDA 510(k)

FDA Class 2 ·General Hospital

COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

THERAPY CHAIR SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

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