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 ·RIGID GAS PERMEABLE CONTACT LENSES

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·NOVALENS (ROSILFOCON A)

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·FLUOROPERM 60 (PAFLUFOCON B) 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

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·BOSTON EQUALENS(R) AND BOSTON RXD(R)

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 ·RIGID GAS PERMEABLE CONTACT LENSES

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·OPTACRYL K

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS

Sterilizer, Soft-Lens, Thermal, Ac-Powered

FDA Pre-Market Approval

FDA Class 2 ·HYDROCURVE PATIENT DISINFECTION UNIT

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 60 - CLEAR

H.D. HEALTH DEFENCE S.R.L.

Importer

🇮🇹 Italy

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE CARDIOFORM Septal Occluder

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·SOMO-V AUTOMATED BREAST ULTRASOUND SYSTEM

FDA Pre-Market Approval

HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS

No. V1 097447 0006

Certificate

IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·22 Basic UDI-DIs