| Blazer II Cardiac Ablation Catheter and Cable (P920047/S118) | Boston Scientific Corp | 2019-11-07 |
| Ceramax Ceramic Total Hip System (P070026/S069) | DePuy Orthopaedics, Inc. | 2019-11-07 |
| Edwards Intuity Elite Valve System (P150036/S042) | Edwards Lifesciences, LLC | 2019-11-07 |
| Express SD Monorail Premounted Stent System (P060006/S098) | Boston Scientific Corp | 2019-11-07 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S062) | Boston Scientific Corp | 2019-11-07 |
| PROMUS Element Plus and Promus PREMIER and Promus ELITE Everolimus-Eluting Stent System (P110010/S171) | Boston Scientific Corp | 2019-11-07 |
| WOLVERINE Coronary Cutting Balloon (P950020/S099) | Boston Scientific Corp | 2019-11-07 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S050) | Boston Scientific Corp | 2019-11-07 |
| CoreValve Evolut R System, CoreValve Evolut PRO System, and CoreValve Evolut PRO + System (P130021/S068) | Medtronic, Inc. | 2019-11-07 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S091) | Boston Scientific Corp | 2019-11-07 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S284) | Medtronic Neuromodulation | 2019-11-06 |
| Sientra OPUS Silicone Gel Breast Implants (P070004/S024) | Tiger Aesthetics Medical, LLC | 2019-11-06 |
| Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord (P840001/S422) | Medtronic Neuromodulation | 2019-11-06 |
| FoundationOne CDx (P170019/S012) | Foundation Medicine, Inc. | 2019-11-06 |
| Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear (P990018/S005) | Menicon Co, Ltd. | 2019-11-06 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S179) | Medtronic Neuromodulation | 2019-11-06 |
| Activa Deep Brain Stimulation Therapy System (P960009/S341) | Medtronic, Inc. | 2019-11-06 |
| Radiesse Injectable Implant and Radiesse (+) Lidocaine Dermal Filler (P050052/S115) | Merz North America, Inc. | 2019-11-06 |
| Coaptite lnjectable lmplant (P040047/S055) | Merz North America, Inc. | 2019-11-06 |
| Sientra OPUS Silicone Gel Breast Implants (P070004/S025) | Tiger Aesthetics Medical, LLC | 2019-11-06 |
| Radiesse Injectable Implant (P050037/S098) | Merz North America, Inc. | 2019-11-06 |
| HeartWare HVAD System (P100047/S131) | Medtronic | 2019-11-06 |
| Sientra Opus Silicone Gel Breast Implants (P070004/S026) | Tiger Aesthetics Medical, LLC | 2019-11-06 |
| Oxford Partial Knee System (P010014/S096) | Biomet Manufacturing Corp | 2019-11-05 |
| COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S080) | Roche Molecular Systems, Inc. | 2019-11-05 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S051) | Roche Molecular Systems, Inc. | 2019-11-05 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 (P060030/S081) | Roche Molecular Systems, Inc. | 2019-11-05 |
| NeuroPace RNS System (P100026/S076) | NeuroPace, Inc. | 2019-11-05 |
| Praxis Extended RAS Panel (P160038/S014) | Illumina, Inc. | 2019-11-04 |
| Medtronic MiniMed 670G System (P160017/S074) | Medtronic Minimed, Inc. | 2019-11-04 |
| Guardian Connect System (P160007/S027) | Medtronic Minimed | 2019-11-04 |
| Edwards Sapien XT Transcatheter Heart Valve (P130009/S101) | Edwards Lifesciences, LLC | 2019-11-04 |
| Mara Water Vapor Ablation System, Mara Water Vapor Probe Procedure Kit, Mara Water Vapor Probe, Mara Supply and Drain Ac (P160047/S007) | CooperSurgical, Inc. | 2019-11-04 |
| Restylane Lyft with Lidocaine (P040024/S109) | Q-Med AB | 2019-11-04 |
| Medtronic MiniMed 630G System (P150001/S076) | Medtronic Minimed | 2019-11-04 |
| Medtronic MiniMed 530G System (P120010/S135) | Medtronic, Inc. | 2019-11-04 |
| Avery Diaphragm Pacing System (alson known as Breathing Pacemaker System) (P860026/S009) | Avery Biomedical Devices, Inc. | 2019-11-04 |
| Excor Pediatric Ventricular Assist Device (P160035/S011) | Berlin Heart, Inc. | 2019-11-03 |
| Excor Pediatric Ventricular Assist Device (P160035/S012) | Berlin Heart, Inc. | 2019-11-03 |
| DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S083) | Dexcom, Inc. | 2019-11-01 |
| INFUSE Bone Graft (P000054/S056) | Medtronic Sofamor Danek USA, Inc. | 2019-11-01 |
| 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/S682) | Medtronic Cardiac Rhythm Disease Management | 2019-11-01 |
| INFUSE Bone Graft (P050053/S047) | Medtronic, Inc. | 2019-11-01 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S D (P980035/S606) | Medtronic, Inc. | 2019-11-01 |
| 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/S721) | Medtronic Cardiac Rhythm Disease Management | 2019-11-01 |
| RHA 2, RHA 3, RHA 4 dermal fillers (P170002/S004) | Teoxane S.A. | 2019-11-01 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S420) | Medtronic, Inc. | 2019-11-01 |
| INFUSE Bone Graft/Medtronic Interbody Fusion Device (P000058/S075) | Medtronic Sofamor Danek USA, Inc. | 2019-11-01 |
| Promus Premier and Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S170) | Boston Scientific Corp | 2019-11-01 |
| Zenith Dissection Endovascular System (P180001/S001) | William Cook Europe Aps | 2019-10-31 |
| GORE CARDIOFORM ASD Occluder and Septal Occluder (P050006/S080) | W. L. Gore & Associates, Inc. | 2019-10-31 |
| Covera Vascular Covered Stent (P170042/S003) | C.R. Bard, Inc. | 2019-10-31 |
| GORE TAG Thoracic Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S113) | W. L. Gore & Associates, Inc. | 2019-10-31 |
| MiniMed 630G System with SmartGuard (P150001/S075) | Medtronic Minimed | 2019-10-30 |
| LOTUS Edge Valve System (P180029/S008) | Boston Scientific Corporation | 2019-10-30 |
| Gel-One (P080020/S035) | Seikagaku Corp. | 2019-10-30 |
| MiniMed 670G Insulin System (P160017/S073) | Medtronic Minimed, Inc. | 2019-10-30 |
| SURGIFOAM Absorbable Gelatin Sponge, U.S.P. (P990004/S036) | Ferrosan Meidcal Devices A/S | 2019-10-30 |
| IMPELLA 2.5 System, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella 5.5 with SmartAssist and Impella LD (P140003/S061) | Abiomed, Inc. | 2019-10-30 |
| Enveo R and EnVeo PRO Delivery Catheter System of the CoreValve (P130021/S065) | Medtronic, Inc. | 2019-10-30 |
| VICI VENOUS STENT System (P180013/S001) | Boston Scientific Corporation | 2019-10-30 |
| Relay Thoracic Stent-Graft with Plus Delivery System (P110038/S024) | Bolton Medical, Inc. | 2019-10-30 |
| SURGICEL Powder (N12159/S065) | ETHICON, Inc. | 2019-10-30 |
| Evolut R and CoreValve Evolut PRO Systems (P140017/S017) | Medtronic, Inc. | 2019-10-30 |
| Impella RP System (P170011/S017) | Abiomed, Inc. | 2019-10-30 |
| Sientra OPUS Silicone Gel Breast Implants (P070004/S021) | Tiger Aesthetics Medical, LLC | 2019-10-29 |
| Eversense Continuous Glucose Monitoring System (P160048/S014) | Senseonics, Incorporated | 2019-10-29 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S130) | Boston Scientific Corporation | 2019-10-29 |
| Cardiac Resynchronization Therapy - Pacemaker (CRT-P) (P030005/S190) | Guidant Corp. | 2019-10-29 |
| Implantable Cardioverter Defibrillator (ICD) (P960040/S443) | Boston Scientific | 2019-10-29 |
| Sientra OPUS Silicone Gel Breast Implants (P070004/S022) | Tiger Aesthetics Medical, LLC | 2019-10-29 |
| CardioMEMS HF System (P100045/S040) | ABBOTT MEDICAL | 2019-10-29 |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D) (P010012/S510) | Boston Scientific Corp | 2019-10-29 |
| Non-MRI Pacemakers (N970003/S244) | Boston Scientific Corp | 2019-10-29 |
| CoreValve Evolut R and Evolut PRO Systems (P130021/S066) | Medtronic, Inc. | 2019-10-29 |
| MRI Pacemakers (P150012/S084) | Boston Scientific | 2019-10-29 |
| RHA 2, RHA 3, and RHA 4 Dermal Fillers (P170002/S005) | Teoxane S.A. | 2019-10-29 |
| XVIVO Perfusion System (XPS) with STEEN Solution Perfusate (P180014/S001) | Xvivo Perfusion, Inc. | 2019-10-29 |
| Edwards Pericardial Aortic Bioprosthesis, Inspiris Resilia Aortic Valve, and Edwards Pericardial Mitral Bioprosthesis (P150048/S039) | Edwards Lifesciences, LLC | 2019-10-28 |
| Edwards Sapien XT Transcatheter Heart Valve (P130009/S103) | Edwards Lifesciences, LLC | 2019-10-28 |
| Edwards Intuity Elite Valve (P150036/S043) | Edwards Lifesciences, LLC | 2019-10-28 |
| Perimount Bioprosthesis, Perimount Magna Aortic Bioprosthesis, Perimount Magna Ease Bioprosthesis, and Perimount Plus Bi (P860057/S192) | Edwards Lifesciences, LLC | 2019-10-28 |
| Edwards Sapien 3 Transcatheter Heart Valve and Edward Sapien 3 Ultra Transcatheter Heart Valve (P140031/S098) | Edwards Lifesciences, LLC | 2019-10-28 |
| CERAMAX Ceramic Total Hip System (P070026/S062) | DePuy Orthopaedics, Inc. | 2019-10-27 |
| Ceramax Ceramic Total Hip System (P070026/S061) | DePuy Orthopaedics, Inc. | 2019-10-27 |
| TactiCath Quartz Contact Force Ablation Catheter and TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S052) | St Jude Medical | 2019-10-25 |
| Amplatzer Septal Occluder and Amplatzer Multi-Fenestrated Septal Occluder (P000039/S068) | ABBOTT MEDICAL | 2019-10-25 |
| Bellafill Dermal Filler (P020012/S035) | Tiger Aesthetics Medical, LLC | 2019-10-25 |
| ADVIA Centaur HBsAg (P030049/S013) | Siemens Healthcare Diagnostics | 2019-10-25 |
| Frequency 55 Toric (methafilcon A) (P850079/S081) | CooperVision, Inc. | 2019-10-25 |
| Aspire Cristalle Digital Breast Tomosynthesis Option (P160031/S002) | Fujifilm Medical Systems U.S.A, Inc. | 2019-10-25 |
| LIFEPAK 20e Defibrillator/Monitor (P160026/S010) | Physio-Control, Inc. | 2019-10-25 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S053) | Coloplast Corp. | 2019-10-25 |
| Bond Oracle HER2 IHC System (P090015/S009) | Leica Biosystems | 2019-10-25 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S026) | Nevro Corporation | 2019-10-25 |
| Tendril ST/STS Steroid Eluting Cardiac Leads (P960013/S108) | ABBOTT MEDICAL | 2019-10-25 |
| HOYA iSert 250/251 and Clarisert Pre-Loaded IOL Injector System (P080004/S023) | Hoya Surgical Optics, Inc. | 2019-10-25 |
| Amplatzer PFO Occluder (P120021/S013) | ABBOTT MEDICAL | 2019-10-25 |
| Livewire TC Ablation, Livewire TC Cables, Safire Ablation Catheter and Safire Cables (P960016/S080) | St Jude Medical | 2019-10-25 |
| HiResolution Bionic Ear System (P960058/S143) | Advanced Bionics | 2019-10-25 |