Portare System (FA-001)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

KIRSCHNER MODULAR HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

KIRSCHNER BIPOLAR ENDOPROSTHETIC HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

HISTOFREEZER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PYXIS 3D Titanium Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

BIO-GUARD O.R. SCRUB PREP TRAY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KIRSCHNER NEER-III MODULAR PROXIMAL HUMERUS

FDA 510(k)

FDA Class 2 ·Orthopedic

Caption Guidance

FDA 510(k)

FDA Class 2 ·Radiology

VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INVADER UGT1A1 MOLECULAR ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

CANDELA GENTLEMAX FAMILY OF LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IR-192 IMPLANT

FDA 510(k)

FDA Class 2 ·Radiology

Caption Guidance

FDA 510(k)

FDA Class 2 ·Radiology

Caption Interpretation Automated Ejection Fraction Software

FDA 510(k)

FDA Class 2 ·Radiology

LESTER PRESS FIT HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

AUSTIN-MOORE TYPE HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

DIMENSION-II TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

REPLICA(TM) TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Eko Low Ejection Fraction Tool (ELEFT)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICROPLATE CANNABINOIDS ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology