Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER PFO OCCLUDER

GUM®

FDA UDI

SUNSTAR AMERICAS, INC.·00070942306799·ORTHODONTIC KIT

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)

HGI Europe Oy

Importer

🇫🇮 Finland·2 Manufacturers

Oragene Dx

FDA UDI

DNA Genotek Inc·00627595000132·DNA Specimen Collection, Saliva

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·BAROSTIM NEO® System

Oragene Dx

FDA UDI

DNA Genotek Inc·00627595000248·DNA Specimen Collection, Saliva

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER M1000

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·RIGID GAS PERMEABLE CONTACT LENSES

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·BOSTON(R) RXD(TM)(ITABISFLUOROFOCON A) BIFOCAL LEN

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·O-PERM F60 RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OCUSIL(TM) CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OPTACRYL 60 - CLEAR

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·O-PERM F60 RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OPTACRYL II BLUE

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOREX (TM) 600 (FLURSILFOCON A)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OCUSIL(TM) CONTACT LENS