5,697 results · 42ms · Sources: EU EUDAMED, US FDA

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

APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

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

No. V1 097447 0006

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

No. V1 097447 0006

Certificate
IVDD Annex IV (excluding sections 4, 6)·HMD Biomedical Inc.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

Motex Anti-Fog Surgical Face Mask

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK PRIZM AVT AICD SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VITALITY AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS AND MODEL 2857 SOFTWARE, VERSION 1.6

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK PRIZM 2 VR/DR MODELS 1860/1861, VENTAK PRIZM VR/DR MODELS 1850/1851/1855/