| On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study (P000037/S054) | On-X Life Technologies, Inc. | 2019-08-15 |
| iPro2 System (P150029/S030) | Medtronic Minimed | 2019-08-14 |
| Astron Pulsar/Pulsar-18 Stent Systems (P160025/S008) | Biotronik AG | 2019-08-14 |
| Medtronic Minimed 630G Insulin Pump (P150001/S072) | Medtronic Minimed | 2019-08-14 |
| Paradigm Real-Time Revel System (P150019/S057) | Medtronic Minimed | 2019-08-14 |
| InterStim Therapy System, Verify Evaluation System (P080025/S190) | Medtronic Neuromodulation | 2019-08-14 |
| BioGlue Surgical Adhesive (P010003/S036) | Cryolife, Inc. | 2019-08-14 |
| MiniMed 530G System (P120010/S132) | Medtronic, Inc. | 2019-08-14 |
| Paradigm Real-Time System and Paradigm Real-Time Revel System (P980022/S208) | Medtronic Minimed | 2019-08-14 |
| Guardian Connect System (P160007/S024) | Medtronic Minimed | 2019-08-14 |
| SURGICEL Nu-Knit Absorbable Hemostat (N12159/S062) | ETHICON, Inc. | 2019-08-14 |
| Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces Specify and Vectris Spinal Cord S (P840001/S439) | Medtronic Neuromodulation | 2019-08-14 |
| InterStim Therapy System, Verify Evaluation System (P970004/S295) | Medtronic Neuromodulation | 2019-08-14 |
| Surgicel Powder Absorbable Hemostatic Powder (N12159/S057) | ETHICON, Inc. | 2019-08-14 |
| Implantable System for Remodulin (P140032/S037) | Medtronic, Inc. | 2019-08-14 |
| Ceramax Ceramic Total Hip System (P070026/S067) | DePuy Orthopaedics, Inc. | 2019-08-14 |
| MiniMed 670G System (P160017/S069) | Medtronic Minimed, Inc. | 2019-08-14 |
| SynchroMed Infusion System Ascenda Intrathecal Catheters (P860004/S335) | Medtronic, Inc. | 2019-08-14 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S010) | Biotronik AG | 2019-08-14 |
| Activa Deep Brain Stimulation Therapy System (P960009/S354) | Medtronic, Inc. | 2019-08-14 |
| cobas AmpliPrep/cobas TaqMan CMV Test (P110037/S048) | Roche Molecular Systems, Inc. | 2019-08-13 |
| Architect Anti-HCV and Alinity i Anti-HCV (P050042/S039) | Abbott Laboratories, Inc. | 2019-08-13 |
| cobas AmpliPrep/cobas TaqMan HBV Test, v2 (P050028/S077) | Roche Molecular Systems, Inc. | 2019-08-13 |
| OPTIMIZER Smart System (P180036/S002) | Impulse Dynamics (Usa), Inc. | 2019-08-13 |
| cobas AmpliPrep/cobas TaqMan HCV Test, v2 (P060030/S078) | Roche Molecular Systems, Inc. | 2019-08-13 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S043) | Abbott Diabetes Care, Inc. | 2019-08-13 |
| Restylane Refyne, Restylane Defyne (P140029/S017) | Q-Med AB | 2019-08-13 |
| FreeStyle Libre 14 day Flash Glucose Monitoring System (P160030/S036) | Abbott Diabetes Care, Inc. | 2019-08-13 |
| Resolute Onyx Coronary Stent Systems (P160043/S026) | Medtronic Vascular | 2019-08-12 |
| VenaSeal Closure System (P140018/S016) | Medtronic Vascular, Inc. | 2019-08-12 |
| Resolute Integrity Coronary Stent Systems (P110013/S099) | Medtronic Vascular | 2019-08-12 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S019) | ABBOTT MEDICAL | 2019-08-12 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S072) | ABBOTT MEDICAL | 2019-08-12 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S052) | Beckman Coulter, Inc. | 2019-08-09 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) (P150003/S051) | Boston Scientific Corporation | 2019-08-09 |
| Zoll R Series (P160022/S011) | ZOLL Medical Corporation | 2019-08-09 |
| LifeVest Wearable Defibrillator (P010030/S123) | Zoll Manufacturing Corporation | 2019-08-09 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S026) | Beckman Coulter, Inc. | 2019-08-09 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S045) | Beckman Coulter, Inc. | 2019-08-09 |
| Transcend Hip Articulation System (P010001/S020) | Ceramtec GmbH | 2019-08-09 |
| comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S095) | CooperVision, Inc. | 2019-08-09 |
| Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S040) | Beckman Coulter, Inc. | 2019-08-09 |
| Algovita Spinal Cord Stimulation System (P130028/S026) | Nuvectra Corporation | 2019-08-09 |
| NeuroPace RNS System (P100026/S073) | NeuroPace, Inc. | 2019-08-08 |
| Obalon Balloon System (P160001/S042) | Medtimo, Inc. | 2019-08-08 |
| INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Interga Omnigraft Dermal Regenerat (P900033/S082) | Integra Lifesciences Corp. | 2019-08-08 |
| Praxis Extended RAS Panel (P160038/S013) | Illumina, Inc. | 2019-08-08 |
| Euclid Systems Orthokeratology (oprifoconA)/ Contact Lenses for Overnight Wear/Euclid Systems Orthokeratology (tisilfoco (P040029/S006) | Euclid Vision Corporation | 2019-08-07 |
| Nexgen LPS-Flex/LPS-Mobile Bearing Knee (P060037/S061) | Zimmer, Inc. | 2019-08-07 |
| Prometra II Programmable Infusuin Pump System (P080012/S059) | Infusyn Therapeutics, LLC | 2019-08-07 |
| TECNIS iTec Preloaded Delivery System (P980040/S105) | Johnson & Johnson Surgical Vision, Inc. | 2019-08-07 |
| Evera MRI DF-1, Evera S DR/VR, Evera XT DR/VR, Mirro MRI DR/VR, Primo MRI DR/VR, Protecta VR/XT, Secura DR, Visia AF MRI (P980016/S716) | Medtronic Cardiac Rhythm Disease Management | 2019-08-06 |
| Consulta, Percepta Bipolar, Percepta Quadripolar, Serena Bipolar, Serena Quadripolar, Solara Bipolar, Solara quadripolar (P010015/S416) | Medtronic, Inc. | 2019-08-06 |
| enVista Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S038) | Bausch & Lomb, Inc. | 2019-08-06 |
| Inspire Upper Airway Stimulation (UAS) (P130008/S043) | Inspire Medical Systems | 2019-08-06 |
| MANTA Vascular Closure Device (P180025/S005) | Teleflex Medical, LLC | 2019-08-06 |
| Oxford Partial Knee System (P010014/S090) | Biomet Manufacturing Corp | 2019-08-06 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S065) | DePuy Orthopaedics, Inc. | 2019-08-06 |
| Amplia MRI/Quad, Brava/Quad, Claria MRI/Quad, Compia MRI/Quad, Consulta, Protecta/XT, Viava Quad S/XT, Viva S/XT CRT-D (P010031/S677) | Medtronic Cardiac Rhythm Disease Management | 2019-08-06 |
| RxSight Light Adjustable Lens and Light Delivery Device (P160055/S005) | Rxsight, Inc. | 2019-08-06 |
| Adapta, Versa, Sensia, Advisa DR/SR MRI, Astra S DR/SR MRI, Astra XT DR/SR, Attesta DR/SR MRI, Azure S DR/SR MRI, Relia, (P980035/S602) | Medtronic, Inc. | 2019-08-06 |
| BIOLON (P960011/S032) | Altacor , Ltd. | 2019-08-05 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S005) | Berlin Heart, Inc. | 2019-08-05 |
| SURGICEL BRAND ABSORBABLE HEMOSTAT (N12159/S061) | ETHICON, Inc. | 2019-08-02 |
| Surgical Absorbable Hemostats (N12159/S060) | ETHICON, Inc. | 2019-08-02 |
| EZ Steer Thermocool NAV Catheter and Navistar Thermocool (P040036/S068) | Biosense Webster, Inc. | 2019-08-02 |
| Celsius Catheter (P950005/S072) | Biosense Webster, Inc. | 2019-08-02 |
| Celsius, EZ Steer, and Navistar Thermocool Catheter (P030031/S099) | Biosense Webster, Inc. | 2019-08-02 |
| Bone Growth Stimulators (P910066/S030) | Djo, LLC | 2019-08-02 |
| M6-C Artificial Cervical Disc (P170036/S001) | Spinal Kinetics, LLC | 2019-08-02 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra (P980035/S582) | Medtronic, Inc. | 2019-08-01 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S091) | Alcon Research, Ltd. | 2019-08-01 |
| Zephyr Endobronchial Valve (EBV) System (P180002/S007) | Pulmonx Corporation | 2019-08-01 |
| Micra TPS (P150033/S050) | Medtronic, Inc. | 2019-08-01 |
| Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P170035/S004) | Bausch and Lomb, Inc., | 2019-08-01 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S398) | Medtronic, Inc. | 2019-08-01 |
| NeuroPace RNS System (P100026/S070) | NeuroPace, Inc. | 2019-08-01 |
| PMMA Multi-Piece Posterior Chamber Intraocular Lens (P810032/S070) | Alcon Laboratories | 2019-08-01 |
| PMMA Single-Piece Posterior Chamber Intraocular Lens (P840060/S047) | Alcon Laboratories | 2019-08-01 |
| AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S123) | Alcon Laboratories, Inc. | 2019-08-01 |
| Evera RI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mi (P980016/S701) | Medtronic Cardiac Rhythm Disease Management | 2019-08-01 |
| PMMA Single-Piece Anterior Chamber Intraocular Lens (P880087/S029) | Alcon Laboratories | 2019-08-01 |
| 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/S661) | Medtronic Cardiac Rhythm Disease Management | 2019-08-01 |
| LCS Total Knee System - Attune Revision Tibial Sleeves (P830055/S233) | Depuy, Inc. | 2019-08-01 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S044) | Beckman Coulter, Inc. | 2019-07-31 |
| Absolute Pro Vascular Self-Expanding Stent System (P110028/S020) | Abbott Vascular, Inc. | 2019-07-31 |
| C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) (P060011/S018) | Rayner Intraocular Lenses , Ltd. | 2019-07-31 |
| Resonate, Momentum, Vigilant, Autogen, Dynagen, Inogen, and Origen Cardiac Resynchronization Therapy Defibrillators (CRT (P010012/S504) | Boston Scientific Corp | 2019-07-31 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S051) | Beckman Coulter, Inc. | 2019-07-31 |
| Belotero Balance (P090016/S033) | Merz North America, Inc. | 2019-07-31 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S025) | Beckman Coulter, Inc. | 2019-07-31 |
| Ingevity MRI Leads and Slit Suture Sleeve Accessory for Ingevity Leads (P150012/S078) | Boston Scientific | 2019-07-31 |
| Axium Neurostimulator System (P150004/S030) | ABBOTT MEDICAL | 2019-07-31 |
| Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S039) | Beckman Coulter, Inc. | 2019-07-31 |
| PERLANE (P040024/S108) | Q-Med AB | 2019-07-31 |
| Resonate, Momentum, Vigilant, Perciva, Autogen, Dynagen, Inogen, and Origen Implantable Cardioverter Defibrillators (ICD (P960040/S438) | Boston Scientific | 2019-07-31 |
| Reliance 4-Front Leads, Suture Sleeve Accessory for Reliance 4-Front Leads, Endotak Reliance 4-Site Leads and Endotak Re (P910073/S155) | Boston Scientific | 2019-07-31 |
| FineLine II Sterox Leads, Fineline II Sterox EZ Leads, and Suture Sleeve Accessories for FineLine II Leads (P960004/S090) | Boston Scientific | 2019-07-31 |
| PD-L1 IHC 22C3 pharmDx (P150013/S016) | Agilent Technologies, Inc. | 2019-07-30 |
| Zephyr Endobronchial Valve (EBV) System (P180002/S005) | Pulmonx Corporation | 2019-07-30 |