Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·GELSYN-3

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 HF -T QP, Ilivia Neo 7 HF -T, Intica Neo 7 HF -T QP, Intica Neo 7 HF -T, Intica Neo 5 HF -T QP, Intica Neo

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 DF4 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR-T

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Permanent Implantable

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS PC-43,44,45 NB UV ABSORBING IOL

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX FAMILY OF ICDS AND CRT-DS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Rayner C-flex 570C, C-Flex Aspheric 970C and 600C Aspheric Intraocular lenses

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·COMBI 40+COCHLEAR IMPLANT SYSTEM,C40+S(COMPRESSED)ELECTRODE ARRAY/C40+ GB (SPLIT) ELECTRODE ARRAY

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRO+/TEMPO+ SPEECH PROCESSORS

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 ·COMBI 40+ COCHLEAR IMPLANT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRP+/TEMPO+ SPEECH PROCESSORS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM; MED-EL COMBI 40+ (STANDARD), COMBI 40+S (COMPRESSED), AND COMBI 40+ GB (SPLITS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NovaSure Impedance Controlled Endometrial Ablation System

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Mara Vapor System