CMV EARLY ANTIGEN TEST

FDA 510(k)

FDA Class 2 ·Microbiology

HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

INVIRO SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN)

FDA 510(k)

FDA Class 2 ·Hematology

AUTO-VAC BIOPSY NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INFRARED EAR THERMOMETER, MODEL DX-707

FDA 510(k)

FDA Class 2 ·General Hospital

BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Intra medullary endo-transilluminating device (iMET device)

FDA 510(k)

FDA Class 2 ·Orthopedic

DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

hekaDrill

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SIMPLA S4, S5, S7

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

hekaDrill

FDA 510(k)

FDA Class 2 ·Neurology

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

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter