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

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

EFAI ChestSuite XR Pleural Effusion Assessment System

FDA 510(k)

FDA Class 2 ·Radiology

RELYX LUTING PLUS AUTOMIX

FDA 510(k)

FDA Class 2 ·Dental

USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

HM-RUBY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTS

FDA 510(k)

FDA Class 2 ·Orthopedic

SPECTRUM MODULAR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OSTEONICS RESTORATION MONOLITHIC HIP STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OSTEONICS RESTORATION CEMENTED HIP STEM SERIES

FDA 510(k)

FDA Class 2 ·Orthopedic

DORSAL INTRAMEDULLARY PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic