Device Name
|
Category
|
Date
|
Zenith Dissection Endovascular System - P180001 |
Artery |
12/31/18 |
Woven EndoBridge (WEB) Aneurysm Embolization System - P170032 |
Aneurysm |
12/31/18 |
LIFEPAK® CR2 Defibrillator - P170018 |
Defibrillator |
12/21/18 |
Exablate Model 4000 System - Type 1.0 and 1.1 (Exablate Neuro) P150038/S006 |
Ultrasound |
12/16/18 |
Resolute Onyx Zotarolimus Eluting Coronary Stent System - P160043/S012 |
Stent |
12/14/18 |
Pipeline Flex Embolization Device - P100018/S015 |
Aneurysm |
12/14/18 |
Resolute Integrity Zotarolimus Eluting Coronary Stent System - P110013/S088 |
Stent |
12/14/18 |
Cardiac Science Powerheart® AED G3 Pro – P160034 |
Automatic External Defibrillator (AED) |
12/07/18 |
Cardiac Science Powerheart® AED G3, G3 Plus, and G5 – P160033 |
Automatic External Defibrillator (AED) |
12/07/18 |
Spiration Valve® System - P180007 |
Emphysema |
12/03/18 |
VASCADE® MVP Venous Vascular Closure System (VVCS) - P120016/S024 |
Vascular |
11/27/18 |
INCRAFT® AAA Stent Graft System - P150002 |
Aneurysm |
11/27/18 |
GORE® Carotid Stent – P180010 |
Carotid Stent |
11/01/18 |
Valiant Navion Thoracic Stent Graft System - P100040/S036 |
Stent |
10/19/18 |
HeartMate 3 Left Ventricular Assist System (LVAS) - P160054/S008 |
Heart Pump |
10/18/18 |
VisuMax Femtosecond Laser - P150040/S003 |
Ophthalmic Surgical Laser |
10/04/18 |
BioMimics 3D Vascular Stent System - P180003 |
Stent |
10/04/18 |
Eluvia Drug-Eluting Vascular Stent System - P180011 |
Stent |
09/18/18 |
PK Papyrus Covered Coronary Stent System - H170004 |
Stent |
09/14/18 |
Visian® Toric ICL (Implantable Collamer® Lens) - P030016/S001 |
Implantable Lens |
09/13/18 |
PD-L1 IHC 22C3 pharmDx - P150013/S011 |
Cancer |
08/16/18 |
Hydrus® Microstent - P170034 |
Intraocular |
08/10/18 |
Edwards Pericardial Mitral Bioprosthesis, Model 11000M - P150048/S012 |
Artificial Heart Valve |
08/09/18 |
Covera Vascular Covered Stent - P170042 |
Stent |
07/30/18 |
Magtrace and Sentimag Magnetic Localization System - P160053 |
Breast Cancer |
07/24/18 |
Freestyle Libre 14 Day Flash Glucose Monitoring System - P160030/S017 |
Glucose Monitoring |
07/23/18 |
Abbott RealTime IDH1 - P170041 |
Leukemia |
07/20/18 |
Surpass Streamline Flow Diverter - P170024 |
Stent |
07/13/18 |
Zephyr® Endobronchial Valve System - P180002 |
Bronchial Valve |
06/29/18 |
t:slim X2 Insulin Pump with Basal-IQ Technology - P180008 |
Glucose Monitor |
06/21/18 |
Minimed 670G System - P160017/S031 |
Glucose Monitor |
06/21/18 |
Eversense Continuous Glucose Montioring System - P160048 |
Glucose Monitor |
06/21/18 |
iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) - P170043 |
Stent delivery tool |
06/21/18 |
AUGMENT® Injectable - P100006/S005 |
Bone Fusion |
06/12/18 |
PD-L1 IHC 22C3 pharmDx - P150013/S009 |
Cancer |
06/12/18 |
enVista® One Piece Hydrophobic Acrylic Toric Intraocular Lens - P910056/S027 |
Intraocular Lens |
06/08/18 |
CustomFlexTM Artificial Iris - P170039 |
Artificial Iris |
05/30/18 |
Restylane Lyft with Lidocaine - P040024/S099 |
Dermal Filler |
05/18/18 |
SYNOJOYNTTM - P170016 |
Injection |
05/08/18 |
Bausch + Lomb ULTRA (samfilcon A) Contact Lenses - P170035 |
Contact Lens |
04/30/18 |
PartoSure test - P160052 |
PAMG-1 Test |
04/30/18 |
Medtronic DBS System for Epilepsy - P960009/S219 |
Epilepsy |
04/27/18 |
Medtronic IN.PACTTM AdmiralTM Paclitaxel-Coated PTA Balloon Catheter - P140010/S037 |
Catheter |
04/19/18 |
ThinPrep Integrated Imager - P950039/S036 |
Cervical Cancer |
04/18/18 |
AngelMed Guardian System - P150009 |
Cardiac Monitor |
04/09/18 |
FoundationFocus CDxBRCA LOH - P160018/S001 |
Ovarian Cancer |
04/06/18 |
GORE® CARDIOFORM Septal Occluder - P050006/S060 |
Heart Implant |
03/30/18 |
TransMedics, Inc. TransMedics OCS Lung System - P160013 |
Lung preservation system |
03/22/18 |
LIPOSORBER® LA-15 System - H170002 |
Cholesterol |
03/20/18 |
Guardian Connect System - P160007 |
Glucose Monitor |
03/08/18 |
Abbott Perclose ProGlide Suture-Mediated Closure System - P960043/S097 |
Suture |
02/16/18 |
MiniMed 630G System with SmartGuard - P150001/S021 |
Glucose Monitor |
02/13/18 |
MiniMed 670G System - P160017/S017 |
Glucose Monitor |
02/13/18 |
BD Onclarity HPV Assay - P160037 |
HPV Test |
02/12/18 |
Impella Ventricular Support Systems - P140003/S018 |
Heart Pump |
02/07/18 |
Lifeline/ReviveR ECG and DDU Automated Defibrillators - P160032 |
Defibrillators |
02/01/18 |
Aptima HBV Quant assay - P170025 |
HBV Test |
01/28/18 |