Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Combi 40+ Cochlear Implant System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·COCHLEAR NUCLEUS C1512 IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HARMONY HIRESOLUTION BIONIC EAR SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus N22 Cochlear Implant Systems

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus 24 Cochlear Implant System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO System Software 9.0

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE-FILLED BREAST IMPLANTS

Stent, Urethral, Prostatic, Semi-Permanent

FDA classification

FDA Class 3 ·Stent, Urethral, Prostatic, Semi-Permanent

Pediatric Esophageal Atresia Anastomosis Device

FDA classification

FDA Class 3 ·Pediatric Esophageal Atresia Anastomosis Device

Optical Diagnostic Device For Melanoma Detection

FDA Pre-Market Approval

FDA Class 3 ·MELAFIND