10,000 results · 34ms · Sources: EU EUDAMED, US FDA

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION DEVICE FITTING SOFTWARE (SCLIN)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CPI SWITCH BOX

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (ADULT)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT(ADULT) HIFOCUS ELECTRODE

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION MULTI-STRATEGY COCHLEAR IMPLANT (ADULT)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM (ADULT)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION MULTI-STRATEGY COCHLEAR IMPLANT (ADULT)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE FIREFLY (ADULT)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CALRION CII BIONIC EAR SYSTEM (ADULT)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION CII BIONIC EAR, HIFOCUS ELECTRODE WITHOUT POSITIONER (MODEL AB-5100H-11A) & HIRES SOFTWARE (MODEL CI-6055)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE(BEHIND-THE-EAR)T-MIC

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·PLATINUM SOUND PROCESSOR (COCHLEAR IMPLANT)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·BTE (BEHIND-THE-EAR) SYSTEM SENSOR (ADULT)

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·CLARION MULTI-STRATEGY COCHLEAR IMPLANT(ADULT)

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·TECHNOLAS 217Z ZYOPTIX SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval
FDA Class 3 ·INOUE-BALLOON Catheter

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval
FDA Class 3 ·INOUE BALLOON CATHETER