| Tendril SDX, OptiSense, Tendril STS and Tendril ST Low Voltage Active Fixation Leads (P960013/S105) | ABBOTT MEDICAL | 2018-12-05 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, SPhera DR MRI IPG, and Sphera SR MRI IPG (P980035/S572) | Medtronic, Inc. | 2018-12-05 |
| QuickFlex u, Quartet Cardiac Resynchronization Therapy (CRT) Passive Fixation Leads (P030054/S366) | ABBOTT MEDICAL | 2018-12-05 |
| NexGen LPS-Flex/LPS-Mobile Bearing Knee (P060037/S057) | Zimmer, Inc. | 2018-12-05 |
| Oxford Partial Knee System (P010014/S083) | Biomet Manufacturing Corp | 2018-12-05 |
| Isoflex Low Voltage Passive Fixation Leads (P960030/S064) | ABBOTT MEDICAL | 2018-12-05 |
| Watchman LAA Closure Technology (P130013/S022) | Boston Scientific Corp | 2018-12-04 |
| Dexcom G5 Platinum Contiuous Glucose Monitoring System (P120005/S079) | Dexcom, Inc. | 2018-12-04 |
| Spiration® Valve System (P180007) | Gyrus Acmi, Inc. | 2018-12-03 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S387) | Medtronic, Inc. | 2018-12-03 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, COmpia (P010031/S656) | Medtronic Cardiac Rhythm Disease Management | 2018-12-03 |
| Adapta Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, A (P980035/S571) | Medtronic, Inc. | 2018-12-03 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Protecta ICD, Protecta VR/XT ICD, Secura DR IC (P980016/S697) | Medtronic Cardiac Rhythm Disease Management | 2018-12-03 |
| LCS Total Knee System (P830055/S211) | Depuy, Inc. | 2018-12-03 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S079) | Edwards Lifesciences, LLC | 2018-12-03 |
| REVO MRI SURESCAN IPG AND PACING SYSTEM (P090013/S294) | Medtronic, Inc. | 2018-12-03 |
| Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve (P150048/S030) | Edwards Lifesciences, LLC | 2018-12-03 |
| SlimTip DRG Trial Lead Kit, 50cm/90cm, Slim Tip DRG Implant Lead Kit 50cm/90cm, DRG Lead Extension Kit (P150004/S026) | ABBOTT MEDICAL | 2018-12-03 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S095) | Edwards Lifesciences, LLC | 2018-12-03 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis/Theon Pericardial Aortic Bioprosthesis with ThermaFix tiss (P860057/S186) | Edwards Lifesciences, LLC | 2018-12-03 |
| EDWARDS INTUITY Elite Valve System (P150036/S035) | Edwards Lifesciences, LLC | 2018-12-03 |
| Carpentier-Edwards PERIMOUNT Plus Pericardial Mitral Bioprosthesis/Theon Pericardial Mitral Bioprosthesis with ThermaFix (P860057/S185) | Edwards Lifesciences, LLC | 2018-12-01 |
| EDWARDS INTUITY ELITE Valve/Delivery System (P150036/S036) | Edwards Lifesciences, LLC | 2018-12-01 |
| Biofinity (Comfilcon A) (P080011/S084) | CooperVision, Inc. | 2018-11-30 |
| Paradigm Real-Time Revel System (P150019/S051) | Medtronic Minimed | 2018-11-30 |
| Optune (P100034/S018) | Novocure, GmbH | 2018-11-30 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S280) | Medtronic Neuromodulation | 2018-11-30 |
| iPro2 CGM System with Enlite Sensor (P150029/S024) | Medtronic Minimed | 2018-11-30 |
| Impella CP with SmartAssist (P140003/S043) | Abiomed, Inc. | 2018-11-30 |
| MiniMed 630G System with SmartGuard (P150001/S055) | Medtronic Minimed | 2018-11-30 |
| MiniMed 530G System (P120010/S125) | Medtronic, Inc. | 2018-11-30 |
| MiniMed 630G System (P150001/S054) | Medtronic Minimed | 2018-11-30 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S175) | Medtronic Neuromodulation | 2018-11-30 |
| Activa Deep Brain Stimulation Therapy System (P960009/S330) | Medtronic, Inc. | 2018-11-30 |
| MiniMed Paradigm Real-Time Revel System (P150019/S049) | Medtronic Minimed | 2018-11-30 |
| MiniMed iPro2 CGM System with Enlite Sensor (P150029/S023) | Medtronic Minimed | 2018-11-30 |
| MiniMed 670G System (P160017/S053) | Medtronic Minimed, Inc. | 2018-11-30 |
| Impella CP with SmartAssist (P140003/S042) | Abiomed, Inc. | 2018-11-30 |
| MiniMed 530G System (P120010/S123) | Medtronic, Inc. | 2018-11-30 |
| Itrel, Synergy and Intellis Spinal COrd Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S414) | Medtronic Neuromodulation | 2018-11-30 |
| LAP-BAND Adjustable Gastric Banding System (P000008/S044) | Medtimo, Inc. | 2018-11-30 |
| Guardian Connect System (P160007/S011) | Medtronic Minimed | 2018-11-30 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S002) | Tandem Diabetes Care, Inc. | 2018-11-29 |
| Micra Transcatheter Pacing System (P150033/S047) | Medtronic, Inc. | 2018-11-29 |
| HEMOBLAST Bellows (P170012/S012) | Dilon Technologies, Inc. | 2018-11-29 |
| NeuroPace RNS System (P100026/S061) | NeuroPace, Inc. | 2018-11-29 |
| VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (P040045/S102) | Vistakon, Division of Johnson & Johnson Vision Car | 2018-11-29 |
| LCS Total Knee System (P830055/S216) | Depuy, Inc. | 2018-11-29 |
| Oncomine Dx Target Test (P160045/S012) | Life Technologies Corporation | 2018-11-29 |
| Implantable System for Remodulin (P140032/S022) | Medtronic, Inc. | 2018-11-29 |
| MiniMed 630G System with SmartGuard (P150001/S052) | Medtronic Minimed | 2018-11-29 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S003) | Tandem Diabetes Care, Inc. | 2018-11-29 |
| AEGEA VAPOR SYSTEM, AEGEA VAPOR PROBE PROCEDURE KIT, AEGEA VAPOR GENERATOR AND AEGEA VAPOR GENERATOR ACCESSORY KIT (P160047/S003) | CooperSurgical, Inc. | 2018-11-29 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S001) | Tandem Diabetes Care, Inc. | 2018-11-29 |
| MiniMed 670G System (P160017/S051) | Medtronic Minimed, Inc. | 2018-11-29 |
| EMBLEM S-ICD PG Models A209 and A219 (P110042/S118) | Boston Scientific Corporation | 2018-11-29 |
| LCS Total Knee System (P830055/S218) | Depuy, Inc. | 2018-11-28 |
| SelectSecure Lead (P030036/S107) | Medtronic Cardiac Rhythm Disease Management | 2018-11-28 |
| Blazer II, Blazer II HTD, Blazer Prime HTD (P920047/S113) | Boston Scientific Corp | 2018-11-28 |
| LeukoStrat CDx FLT3 Mutation Assay (P160040/S002) | Invivoscribe Technologies, Inc. | 2018-11-28 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot (P980016/S696) | Medtronic Cardiac Rhythm Disease Management | 2018-11-28 |
| Blazer II XP and Blazer Prime XP (P020025/S116) | Boston Scientific | 2018-11-28 |
| HV Splitter/Adaptor Kit and Sprint Quattro Lead (P920015/S223) | Medtronic, Inc. | 2018-11-28 |
| Orbera Intragastric Balloon (P140008/S014) | Boston Scientific Corporation | 2018-11-28 |
| Algovita Spinal Cord Stimulation System (P130028/S018) | Nuvectra Corporation | 2018-11-28 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S570) | Medtronic, Inc. | 2018-11-28 |
| DuraSeal Dural Sealant System (P040034/S028) | Integra LifeSciences Corporation | 2018-11-28 |
| Amplia MRI CRT-D Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia M (P010031/S655) | Medtronic Cardiac Rhythm Disease Management | 2018-11-28 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S386) | Medtronic, Inc. | 2018-11-28 |
| DuraSeal Exact SPine Sealant System (P080013/S016) | Integra LifeSciences Corporation | 2018-11-28 |
| VASCADE MVP Venous Vascular Closure System (VVCS) (P120016/S024) | Cardiva Medical, Inc. | 2018-11-27 |
| SynchroMed Infusion System, Intrathecal Catheters (P860004/S320) | Medtronic, Inc. | 2018-11-27 |
| INCRAFT(R) AAA STENT GRAFT SYSTEM (P150002) | Cordis US Corporation | 2018-11-27 |
| Precision Novi, Montage, Spectra, Spectra WaveWriter Spinal Cord Stimulator System (SCS) (P030017/S321) | Boston Scientific Corp | 2018-11-27 |
| Vercise Deep Brain Stimulation (DBS)System (P150031/S010) | Boston Scientific Corp | 2018-11-26 |
| Gore Tigris Vascular Stent (P160004/S022) | W. L. Gore & Associates, Inc. | 2018-11-26 |
| RF Marinr Catheters (P930029/S063) | Medtronic, Inc. | 2018-11-26 |
| polymacon Soft (Hydrophilic) Extended Wear Contact Lenses (P780007/S059) | CooperVision, Inc. | 2018-11-23 |
| tetrafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (N17679/S039) | CooperVision, Inc. | 2018-11-23 |
| comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S069) | CooperVision, Inc. | 2018-11-23 |
| cobas HPV Test (P100020/S039) | Roche Molecular Systems, Inc. | 2018-11-23 |
| ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S030) | The Cooper Companies | 2018-11-23 |
| methafilcon A and methafilcon B Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S077) | CooperVision, Inc. | 2018-11-23 |
| Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Precision Spectra WaveWriter Spinal Cord (P030017/S320) | Boston Scientific Corp | 2018-11-23 |
| Medtronic CareLink Model 9986 (2090 CareLink Programmer), Model SW028 (29901 Encore Programmer) (P890003/S396) | Medtronic, Inc. | 2018-11-21 |
| Prolieve Thermodilation System (P030006/S028) | Medifocus, Inc. | 2018-11-21 |
| SURGICEL Endoscopic Applicator (N12159/S047) | ETHICON, Inc. | 2018-11-21 |
| Itrel, Synergy and Intellis Spnal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lead (P840001/S412) | Medtronic Neuromodulation | 2018-11-21 |
| ARCHITECT CORE-M (LN 6l23), Calibrators, Controls and Reagent Kit (P060035/S027) | Abbott Laboratories | 2018-11-20 |
| Obalon Touch Dispenser (P160001/S028) | Medtimo, Inc. | 2018-11-20 |
| MiniMed 670G Insulin Pump Guardian Link (3) Transmitter (P160017/S048) | Medtronic Minimed, Inc. | 2018-11-20 |
| EDWARDS INTUITY Elite Valve System (P150036/S033) | Edwards Lifesciences, LLC | 2018-11-20 |
| Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve (P150048/S027) | Edwards Lifesciences, LLC | 2018-11-20 |
| Oxford Partial Knee System (P010014/S076) | Biomet Manufacturing Corp | 2018-11-20 |
| Oxford Partial Knee System (P010014/S081) | Biomet Manufacturing Corp | 2018-11-20 |
| MiniMed 630G Insulin Pump, Guardian Link (3) Transmitter (P150001/S050) | Medtronic Minimed | 2018-11-20 |
| XIENCE Sierra RX Everolimus Eluting Coronary Stent System (P110019/S103) | Abbott Vascular | 2018-11-20 |
| GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S068) | W. L. Gore & Associates, Inc. | 2018-11-20 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S183) | Edwards Lifesciences, LLC | 2018-11-20 |
| Anchoring Sleeve Kit (P030036/S105) | Medtronic Cardiac Rhythm Disease Management | 2018-11-19 |