Marco Ultra M3, Marco Ultra M4

FDA 510(k)

FDA Class 2 ·Ophthalmic

MHI-TM2000 Linear Accelerator System, VERO, Imavis

FDA 510(k)

FDA Class 2 ·Radiology

Z5 Slit lamp microscope, Z2 Slit lamp microscope

FDA 510(k)

FDA Class 2 ·Ophthalmic

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®

FDA 510(k)

FDA Class 2 ·Neurology

PAP BRUSH

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS

CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Dermalux Flex MD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ECHOVACS

FDA 510(k)

FDA Class 2 ·Radiology

dermalux Flex MD

FDA 510(k)

FDA Class 2 ·Physical Medicine

MICRO HAEMATOCRIT CENTRIFUGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry