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)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target Test (ODxT Test)

Implant, Cochlear

FDA Pre-Market Approval

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

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target Test

Implant, Cochlear

FDA Pre-Market Approval

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

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target Test

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VANTAGE (TETRAFILCON A ) CONTACT LENS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF FAMILY CRT-D'S

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY ICD'S

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 5019 HV SPLITTER/ADAPTOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 7221 B/C/CX/D/E MICRO JEWEL W/MODEL 5434 ACTIVE CAN EMULATOR AND MODEL 9894

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Aptima HPV Assay

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV 16 18/45 GENOTYPE ASSAY

Prostrate Cancer Genes Nucleic Acid Amplification Test System

FDA Pre-Market Approval

FDA Class 3 ·PROGENSA PCA3 ASSAY

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV ASSAY