| Consulta, Syncra, Viva CRT-P (P010015/S351) | Medtronic, Inc. | 2018-01-17 |
| EnVeo PRO Delivery Catheter System, EnVeo PRO Loading System (P130021/S043) | Medtronic, Inc. | 2018-01-17 |
| Plasmaflo (P820033/S011) | Asahi Kasei Medical Co., Ltd. | 2018-01-17 |
| HeartMate 3 Left Ventricular Assist System (P160054/S003) | ABBOTT MEDICAL | 2018-01-16 |
| Impella RP System (P170011/S004) | Abiomed, Inc. | 2018-01-16 |
| Obalon Balloon System (P160001/S010) | Medtimo, Inc. | 2018-01-16 |
| LAP-BAND Adjustable Gastric Banding System (P000008/S040) | Medtimo, Inc. | 2018-01-16 |
| Bard E-LUMINEXX and LIFESTAR Vascular Stents (P080007/S021) | Bard Peripheral Vascular, Inc. | 2018-01-16 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S099) | Boston Scientific Corporation | 2018-01-16 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S295) | Medtronic, Inc. | 2018-01-16 |
| Cardiac Resynchronization Therapy Defibrillator Momentum, Vigilant, Resonate (P010012/S476) | Boston Scientific Corp | 2018-01-15 |
| Implantable Cardioverter Defibrillator / Momentur, Vigilant, Resonate, Perciva (P960040/S417) | Boston Scientific | 2018-01-15 |
| Optiguide Cylindrical Fiber Optic (P940010/S013) | Pinnacle Biologics, Inc. | 2018-01-13 |
| Codman 3000 Implantable Infusion Pump (P890055/S071) | Intera Oncology | 2018-01-12 |
| NovaSure Impedance Controlled Endometrial Ablation System (P010013/S069) | Hologic, Inc. | 2018-01-12 |
| BD Totalys SlidePrep (P970018/S035) | Bd Diagnostic Systems | 2018-01-12 |
| Hancock Modified Orifice Valved Conduit (P790007/S055) | Medtronic Heart Valves | 2018-01-12 |
| Nidek EC-5000 Excimer Laser System (P970053/S017) | Nidek Co., Ltd. | 2018-01-12 |
| Orbera Intragastric Balloon System (P140008/S011) | Boston Scientific Corporation | 2018-01-12 |
| Therascreen EGFR RGQ PCR Kit (P120022/S016) | QIAGEN GmbH | 2018-01-12 |
| Raindrop Near Vision Inlay (P150034/S006) | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2018-01-12 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S100) | Boston Scientific Corporation | 2018-01-12 |
| Freestyle Aortic Root Bioprosthesis (P970031/S062) | Medtronic, Inc. | 2018-01-12 |
| BRACAnalysis CDx (P140020/S012) | Myriad Genetic Laboratories | 2018-01-12 |
| Mosaic Porcine Bioprosthesis (P990064/S074) | Medtronic, Inc. | 2018-01-12 |
| Hancock II Porcine Bioprosthesis (P980043/S065) | Medtronic, Inc. | 2018-01-12 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S296) | Medtronic, Inc. | 2018-01-12 |
| SCS and DBS Leads, Extensions, Anchors, Adapters and Accessories (P010032/S139) | ABBOTT MEDICAL | 2018-01-12 |
| Hancock Modified Orifice Valved Conduit (P870078/S040) | Medtronic, Inc. | 2018-01-12 |
| Implantable Pulse Generators (P140009/S033) | ABBOTT MEDICAL | 2018-01-12 |
| ThermoCool Smart Touch (P030031/S087) | Biosense Webster, Inc. | 2018-01-11 |
| Master Intellis Spinal Cord Stimulation System (P840001/S387) | Medtronic Neuromodulation | 2018-01-11 |
| ThermoCool Smart Touch SF Catheters (P040036/S062) | Biosense Webster, Inc. | 2018-01-11 |
| enVista One Piece Hydrophobic Acrylic Intraocular Lens Vial Manufacturing (P910056/S029) | Bausch & Lomb, Inc. | 2018-01-11 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S026) | Cook Ireland, Ltd. | 2018-01-11 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S389) | Medtronic Neuromodulation | 2018-01-11 |
| Activa Deep Brain Stimulation Therapy System (P960009/S308) | Medtronic, Inc. | 2018-01-11 |
| EMBLEM MRI S-ICD; EMBLEM S-ICD (P110042/S101) | Boston Scientific Corporation | 2018-01-10 |
| Sientra Silicone Breast Implants (P070004/S012) | Tiger Aesthetics Medical, LLC | 2018-01-10 |
| Proclaim Elite IPG (P010032/S140) | ABBOTT MEDICAL | 2018-01-10 |
| Infinity IPG (P140009/S035) | ABBOTT MEDICAL | 2018-01-10 |
| DYNAGEN CRT-D AND X4 CRT-D; INOGEN CRT-D AND X4 CRT-D; ORIGEN CRT-D AND X4 CRT-D; AUTOGEN CRT-D AND X4 CRT-D; INCEPTA, E (P010012/S474) | Boston Scientific Corp | 2018-01-10 |
| DYNAGEN, INOGEN, ORIGEN, AUTOGEN EL ICD; DYNAGEN MINI, INOGEN MINI, ORIGEN MINI ICD; INCEPTA, ENERGEN, PUNCTUA ICD; MOME (P960040/S415) | Boston Scientific | 2018-01-10 |
| Proclaim DRG IPG (P150004/S019) | ABBOTT MEDICAL | 2018-01-10 |
| Dexcon G4 PLATINUM and G5 Mobile Continuous Glucose Monitoring System (P120005/S069) | Dexcom, Inc. | 2018-01-10 |
| AcrySof Aspheric UV Absorbing ReSTOR Toric IOL +2.5 and +3.0 (P040020/S073) | Alcon Research, Ltd. | 2018-01-10 |
| NeuroPace RNS System (P100026/S051) | NeuroPace, Inc. | 2018-01-09 |
| Activa Deep Brain Stimulation Therapy System (P960009/S307) | Medtronic, Inc. | 2018-01-09 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimula (P840001/S388) | Medtronic Neuromodulation | 2018-01-09 |
| S.T.A.R. Ankle System (P050050/S011) | Djo Global | 2018-01-08 |
| NeuroPace RNS System (P100026/S052) | NeuroPace, Inc. | 2018-01-08 |
| AcrySof Intraocular Lenses (P930014/S109) | Alcon Laboratories, Inc. | 2018-01-08 |
| Inspiris Resilia Aortic Valve (P150048/S003) | Edwards Lifesciences, LLC | 2018-01-08 |
| AcrySof ReSTOR Intraocular Lenses (P040020/S077) | Alcon Research, Ltd. | 2018-01-08 |
| Contak Renewal Models H125 and H120 with the Model 2865 Version 1.8 Application Software (P030005/S165) | Guidant Corp. | 2018-01-07 |
| Tendril MRI Cardiac Lead (P140033/S019) | ABBOTT MEDICAL | 2018-01-07 |
| Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead (P150012/S044) | Boston Scientific | 2018-01-07 |
| Latitude Programming System (P910077/S163) | Boston Scientific | 2018-01-07 |
| Pulsar/Pulsar Max Implantable Pulse Generator System with Consult Software (N970003/S217) | Boston Scientific Corp | 2018-01-07 |
| Ventak AV Aicd Ventak Prizm DR/VR, Vitality, Cofient and Teligen Automatic Implantable Cardiovetr Defibrillator System (P960040/S408) | Boston Scientific | 2018-01-07 |
| Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill (P010012/S467) | Boston Scientific Corp | 2018-01-07 |
| CardioMems HF System (P100045/S025) | ABBOTT MEDICAL | 2018-01-05 |
| Medical Adhesive (P880086/S292) | ABBOTT MEDICAL | 2018-01-05 |
| SynchroMed Infusion System, SynchroMed II Infusion Pump (P860004/S281) | Medtronic, Inc. | 2018-01-05 |
| ENDOTAK RELIANCE S /GS /G (P910073/S147) | Boston Scientific | 2018-01-05 |
| Biosense Webster NaviStar ThermoCool Catheter (P030031/S085) | Biosense Webster, Inc. | 2018-01-05 |
| IS4/DF4 Connector Sleeve; Suture Sleeve; Suture Sleeve Kit (P950022/S113) | ABBOTT MEDICAL | 2018-01-05 |
| Lead Cap (IS-1/DF-1/SJ4/DF/IS4) IS4/DF4 Port Plug; DF-1 Receptacle Plug; IS-1 Receptacle Plug (P910023/S399) | ABBOTT MEDICAL | 2018-01-05 |
| Slit Suture Sleeve; Vein Pick (P030054/S343) | ABBOTT MEDICAL | 2018-01-05 |
| Micra Transcatheter Pacemaker System (P150033/S029) | Medtronic, Inc. | 2018-01-05 |
| IN.PACT Admiral Paclitaxel-Coated Balloon Catheter (P140010/S033) | Medtronic, Inc. | 2018-01-05 |
| Juvederm Voluma XC, Juvederm Vollure XC, and Juvederm Volbella XC (P110033/S033) | Allergan | 2018-01-04 |
| BVI 1%OVD (fonnerly BD 1%OVD and Biolon) (P960011/S028) | Altacor , Ltd. | 2018-01-04 |
| HV splitter/adaptor kit; Sprint Quattro Lead (P920015/S205) | Medtronic, Inc. | 2018-01-04 |
| Nevro Corp. Senza Spinal Cord Stimulation (SCS) System (P130022/S013) | Nevro Corporation | 2018-01-04 |
| Attain Performa Lead (P080006/S117) | Medtronic, Inc. | 2018-01-04 |
| Amplia MRI CRT-D / Amplia MRI Quad CRT-D / Brava CRT-D / Brava Quad CRT-D / Claria MRI & Quad Quad CRT-D / Compia MRI & (P010031/S615) | Medtronic Cardiac Rhythm Disease Management | 2018-01-03 |
| OraQuick HCV Rapid Antibody Test (P080027/S031) | OraSure Technologies, Inc. | 2018-01-03 |
| BioGlue Surgical Adhesive (P010003/S029) | Cryolife, Inc. | 2018-01-03 |
| MiniMed 670G System (P160017/S027) | Medtronic Minimed, Inc. | 2018-01-03 |
| Allure, Allure Quadra, Quadra Allure MP (P030035/S163) | ABBOTT MEDICAL | 2018-01-03 |
| Assurity, Assurity+, Endurity (P880086/S291) | ABBOTT MEDICAL | 2018-01-03 |
| Evera MRI ICD / Evera S DR / S VR /XT DR / XT VR ICD; Visia AF MRI VR ICD / Visia AF VR ICD (P980016/S655) | Medtronic Cardiac Rhythm Disease Management | 2018-01-03 |
| RADIESSE Lidocaine Dermal Filler (P050052/S092) | Merz North America, Inc. | 2018-01-02 |
| BVI 1% OVD (1% sodium hyaluronate viscoelastic surgical aid fluid) (P960011/S027) | Altacor , Ltd. | 2018-01-02 |
| Bellafill Dermal Filler (P020012/S017) | Tiger Aesthetics Medical, LLC | 2018-01-02 |
| Integra Dermal Regeneration Template (P900033/S067) | Integra Lifesciences Corp. | 2018-01-02 |
| RADIESSE Injectable Implant (P050037/S078) | Merz North America, Inc. | 2018-01-02 |
| Gelfoam (absorbable gelatin)Sterile Sponge (N18286/S029) | Pfizer, Inc. | 2018-01-02 |
| Tridyne Vascular Sealant (P150016/S008) | Neomend, Inc. | 2018-01-02 |