| Biofinity XR Toric (comfilcon A) (P080011/S087) | CooperVision, Inc. | 2019-10-25 |
| Amplatzer Muscular VSD Occluder (P040040/S038) | ABBOTT MEDICAL | 2019-10-25 |
| Amplatzer Duct Occluder, Amplatzer Duct Occluder II and Amplatzer Septal Occluder (P020024/S058) | ABBOTT MEDICAL | 2019-10-25 |
| Torosa Saline Filled Testicular Prosthesis (P020003/S009) | Coloplast Corp. | 2019-10-25 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S004) | Biotronik AG | 2019-10-25 |
| FlexAbility and FlexAbility SE Ablation Catheter and FlexAbility Cables, Sensor Enabled (P110016/S065) | ABBOTT MEDICAL | 2019-10-25 |
| Algovita Spinal Cord Stimulation System (P130028/S030) | Nuvectra Corporation | 2019-10-25 |
| Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear (P040029/S009) | Euclid Vision Corporation | 2019-10-24 |
| COLOGUARD (P130017/S035) | Exact Sciences Corporation | 2019-10-24 |
| SURGICEL Absorbable Hemostats (N12159/S063) | ETHICON, Inc. | 2019-10-24 |
| Selenia Dimensions 3D System High Resolution Tomosynthesis (P080003/S008) | Hologic, Inc. | 2019-10-24 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S344) | Medtronic, Inc. | 2019-10-24 |
| TENDRIL MRI (P140033/S047) | ABBOTT MEDICAL | 2019-10-24 |
| Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S446) | Medtronic Neuromodulation | 2019-10-24 |
| Activa Deep Brain Stimulation Therapy System (P960009/S360) | Medtronic, Inc. | 2019-10-24 |
| VNS Therapy System (P970003/S227) | LivaNova USA, Inc. | 2019-10-24 |
| EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S065) | Ahp Eos Buyer, Inc. | 2019-10-24 |
| Implantable System for Remodulin (P140032/S042) | Medtronic, Inc. | 2019-10-24 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S171) | W. L. Gore & Associates, Inc. | 2019-10-24 |
| SpF Implantable Spinal Fusion Stimulators (P850035/S054) | Ahp Eos Buyer, Inc. | 2019-10-24 |
| TENDRIL, OPTISENSE (P960013/S109) | ABBOTT MEDICAL | 2019-10-24 |
| Durata and Optisure HV Active Steroid Eluting Cardiac Leads (P950022/S128) | ABBOTT MEDICAL | 2019-10-24 |
| ISOFLEX (P960030/S067) | ABBOTT MEDICAL | 2019-10-24 |
| NexGen LPS-Flex/LPS-Mobile Bearing Knee (P060037/S062) | Zimmer, Inc. | 2019-10-24 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S009) | Berlin Heart, Inc. | 2019-10-23 |
| Attain Performa Lead and Attain Stability Quad MRI Lead (P080006/S141) | Medtronic, Inc. | 2019-10-23 |
| LIFEPAK® CR2 Defibrillator (P170018/S004) | Physio-Control, Inc. | 2019-10-23 |
| Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S445) | Medtronic Neuromodulation | 2019-10-23 |
| OPTIMIZER Smart System (P180036/S003) | Impulse Dynamics (Usa), Inc. | 2019-10-23 |
| myChoice HRD CDx (P190014) | Myriad Genetic Laboratories, Inc. | 2019-10-23 |
| TECNIS Toric II 1-Piece Intraocular Lenses and TECNIS Symfony Toric II Extended Range of Vision Introacular Lensses (P980040/S103) | Johnson & Johnson Surgical Vision, Inc. | 2019-10-23 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S096) | Medtronic Vascular | 2019-10-22 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S025) | Medtronic Vascular | 2019-10-22 |
| Prometra Programmable Infusion Pump System, Pump Firmware Patch 0.28 (P080012/S062) | Infusyn Therapeutics, LLC | 2019-10-22 |
| Cologuard (P130017/S036) | Exact Sciences Corporation | 2019-10-22 |
| TactiCath Quartz Catheter Contact Force Ablation Catheter (P130026/S053) | St Jude Medical | 2019-10-22 |
| Juvederm Injectable Gel Implants, Juvederm Voluma XC, Juvederm Vollure XC, Juvederm Volbella XC (P110033/S040) | Allergan | 2019-10-22 |
| HeartWare HVAD System (P100047/S139) | Medtronic | 2019-10-21 |
| LifeVest Wearable Defibrillator (P010030/S126) | Zoll Manufacturing Corporation | 2019-10-21 |
| Spectranetics Laser Sheaths SLS (P960042/S068) | Spectranetics (Philips) | 2019-10-21 |
| S.T.A.R Ankle System (P050050/S012) | Djo Global | 2019-10-21 |
| CVX-3000 Excimer Lasert System and ELCA Coronary Atherectomy Catheters (P910001/S110) | Spectranetics Corp. | 2019-10-21 |
| Vercise PC and Vercise Gevia Deep Brian Stimulation (DBS) System (P150031/S021) | Boston Scientific Corp | 2019-10-20 |
| Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage and Precision Montage MRI Spinal Cord Stimulato (P030017/S328) | Boston Scientific Corp | 2019-10-20 |
| Pacemaker Devices: ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, and PROPONENT (N970003/S242) | Boston Scientific Corp | 2019-10-18 |
| CRT-D Resynchronization Devices: COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM (P010012/S508) | Boston Scientific Corp | 2019-10-18 |
| HeartWare HVAD System (P100047/S148) | Medtronic | 2019-10-18 |
| Cologuard (P130017/S033) | Exact Sciences Corporation | 2019-10-18 |
| LATITUDE Programming System, Brady v1.06 with Heart Connect (P910077/S173) | Boston Scientific | 2019-10-18 |
| Obalon Balloon System (P160001/S033) | Medtimo, Inc. | 2019-10-18 |
| Pacemaker Devices: INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI (P150012/S081) | Boston Scientific | 2019-10-18 |
| Assurity MRI Pacemakers and Endurity MRI Pacemakers (P140033/S031) | ABBOTT MEDICAL | 2019-10-18 |
| LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab (P190011) | DiaSorin, Inc. | 2019-10-18 |
| Ellipse hybrid (P910023/S420) | ABBOTT MEDICAL | 2019-10-18 |
| Assurity Pacemaker & Endurity Pacemaker (P880086/S299) | ABBOTT MEDICAL | 2019-10-18 |
| ICD Devices: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERC (P960040/S441) | Boston Scientific | 2019-10-18 |
| CRT-P Resynchronization Devices: INVIVE, INTUA, VISIONIST, and VALITUDE (P030005/S188) | Guidant Corp. | 2019-10-18 |
| WATCHMAN Left Atrial Appendage Closure Device (P130013/S033) | Boston Scientific Corp | 2019-10-18 |
| Arctic Front Advance Pro and Arctic Front Advance Cardiac Cryoablation Catheters (P100010/S097) | Medtronic Cryocath, LP | 2019-10-18 |
| Pulse Generator, Permanent Implantable, Pulse-Gererator, Pacemaker External, Adapter and Drug Eluting Permanent Right Ve (P950037/S205) | Biotronik, Inc. | 2019-10-18 |
| Pulse Generator, Pacemaker Implantble with Cardiac Resynchronization (CRT-P) and Drug Eluting Permanent Left Ventricular (P070008/S108) | Biotronik, Inc. | 2019-10-18 |
| Permanent Defibrillator Electrodes, Accessories to Permanent Pacemaker Electrode and Styley Catheter (P980023/S095) | Biotronik, Inc. | 2019-10-18 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, Implantable, dual chamber, Defibrillator, automatic imp (P050023/S136) | Biotronik, Inc. | 2019-10-18 |
| Talent Occluder with Occluder Delivery System (P100021/S078) | Medtronic Vascular | 2019-10-17 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S098) | Medtronic Vascular | 2019-10-17 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S095) | Medtronic Vascular | 2019-10-17 |
| Edwards Expandable Introducer Sheath Set (P130009/S102) | Edwards Lifesciences, LLC | 2019-10-17 |
| Valiant Thoracic Stent Graft With the Captivia Delivery System (P100040/S039) | Medtronic Vascular | 2019-10-17 |
| Edwards eSheath Introducer Set (P140031/S097) | Edwards Lifesciences, LLC | 2019-10-17 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S024) | Medtronic Vascular | 2019-10-17 |
| SynchroMed Infusion System, Ascenda Intratecal Catheters (P860004/S330) | Medtronic, Inc. | 2019-10-16 |
| Juvéderm Voluma, Vollure, Volbella XC (P110033/S050) | Allergan | 2019-10-15 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S072) | W. L. Gore & Associates, Inc. | 2019-10-15 |
| Juvéderm Ultra, Ultra XC, Ultra Plus, and Ultra Plus XC (P050047/S073) | Allergan | 2019-10-15 |
| Sensar 1-Piece IOL, Tecnis 1-Piece IOL, OptiBlue 1-Piece IOL, iTec Preloaded Delivery System, Multifocal 1-Piece IOL, Mu (P980040/S108) | Johnson & Johnson Surgical Vision, Inc. | 2019-10-15 |
| Ellipse, Fortify, Fortify Assura and Quadra Assura MP ICD (P910023/S419) | ABBOTT MEDICAL | 2019-10-15 |
| GORE VIABAHN Endoprosthesis (P040037/S133) | W. L. Gore & Associates, Inc. | 2019-10-15 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S021) | Nevro Corporation | 2019-10-15 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S011) | Celonova Biosciences, Inc. | 2019-10-15 |
| Tecnis 3-Piece Acrylic Monofocal (P990080/S051) | Johnson & Johnson Surgical Vision, Inc. | 2019-10-15 |
| COMBI 40+ Cochlear Implant System (P000025/S113) | Med-El Corp. | 2019-10-15 |
| Sientra Opus Silicone Gel Breast Implants (P070004/S020) | Tiger Aesthetics Medical, LLC | 2019-10-15 |
| Quadra Assura, Unify, Unify Assura and Unify Quadra CRT-D (P030054/S371) | ABBOTT MEDICAL | 2019-10-15 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S343) | Medtronic, Inc. | 2019-10-13 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S301) | Medtronic Neuromodulation | 2019-10-13 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S444) | Medtronic Neuromodulation | 2019-10-13 |
| LOTUS Edge Valve System (P180029/S015) | Boston Scientific Corporation | 2019-10-13 |
| Interm Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S196) | Medtronic Neuromodulation | 2019-10-13 |
| Activa Deep Brain Stimulation Therapy System (P960009/S359) | Medtronic, Inc. | 2019-10-13 |
| Innova Vascular Self-Expanding Stent System (P140028/S044) | Boston Scientific Corporation | 2019-10-11 |
| FoundationOne CDx (P170019/S007) | Foundation Medicine, Inc. | 2019-10-11 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S012) | Boston Scientific Corp | 2019-10-11 |
| i-FACTOR Peptide Enhanced Bone Graft (P140019/S003) | Cerapedics, LLC | 2019-10-11 |
| PartoSure Test (P160052/S001) | Qiagen, Inc. | 2019-10-11 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus ELITE Everolimus-Eluting Platinum C (P110010/S169) | Boston Scientific Corp | 2019-10-11 |
| Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (P160049/S004) | The Spectranetics Corp. | 2019-10-11 |
| LifeVest Wearable Defibrillator (P010030/S124) | Zoll Manufacturing Corporation | 2019-10-11 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S013) | Boston Scientific Corp | 2019-10-11 |
| cobas HBV Test (P150014/S033) | Roche Molecular Systems, Inc. | 2019-10-10 |
| PureVision (balafilcon A) Contact Lens (P980006/S029) | Bausch & Lomb, Inc. | 2019-10-10 |