Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 supported by LATITUDE Consult

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 5348 SINGLE CHAMBER TEMPORARY PACEMAKER (AAI/VVI) AND MODEL 5388 DUAL CHAMBER TEMPORARY PACEMAKER

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR UP TO 30 NIGHTS CONTINUOUS WEAR

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Intellis Spinal Cord Stimulation Systems; Specify and Vectris Spinal Cord Stimulation Leads; Injex lead anchors

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter SPinal Cor

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM, & WITH SURESOUND ULTRINE SOUND, NOVASURE RF CONTROLLER 115V

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ITREL 3 AND 4, SYNERGY, SYNERGY VERSITREL SPINAL CORD STIMULATION SYSTEM;RESTORE RECHARGEABLE NEUROSTIMULATION SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CapSure VDD 2 Lead, Service Kit-Pacemaker Repair Kit and Vitatron Brilliant S+ VDD Lead

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT SYSTEM (10 MM VENOUS ENDOPROSTHESIS) AND UNISTEP PLUS DELIVERY SYSTEM (12 MM VENOUS ENDOPROSTHESIS)

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Valitude CRT-P, Valitude X4 CRT-P, Visionist CRT-P, and Visionist X4 CRT-P

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·COOPERVISION, INC. HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHAFILCON B) SOFT (HYDROPHILIC)...

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spectra, Precision Novi, Precision Montage, and Precision Montage MRI, Spectra WaveWriter Spinal Cord Stimulat

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE WIRE)

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), MODELS H135, H170, H175, H177, AND H179

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Precision Spectra WaveWriter Spinal Cord

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·FlexAbility Ablation Catheter, Sensor Enabled (Bi-Directional) & FlexAbility Ablation Catheter, Sensor Enabled (Uni-Dire