| ADVIA Centaur and Atellica IM cPSA (P990055/S020) | Siemens Healthcare Diagnostics | 2020-03-19 |
| ADVIA Centaur and Atellica IM Anti-HBs2 (aHBs2) (P100039/S008) | Siemens Healthcare Diagnostics, Inc. | 2020-03-19 |
| ADVIA Centaur and Atellica IM HBsAgII (P110041/S008) | Siemens Corp. | 2020-03-19 |
| XIENCE V and XIENCE Nano EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S146) | Abbott Vascular, Inc. | 2020-03-19 |
| ADVIA Centaur and Atellica IM HBc Total (P040004/S016) | Siemens Healthcare Diagnostics | 2020-03-19 |
| ADVIA Centaur and Atellica IM HCV (P030056/S015) | Siemens Healthcare Diagnostics | 2020-03-19 |
| Juvéderm Voluma XC (P110033/S052) | Allergan | 2020-03-18 |
| BRYAN Cervical Disc (P060023/S008) | Companion Spine France Sas | 2020-03-18 |
| Nucleus 24 Cochlear Implant System (P970051/S196) | Cochlear Americas | 2020-03-18 |
| Radiesse(+) Lidocaine (P050052/S119) | Merz North America, Inc. | 2020-03-17 |
| WOLVERINE Coronary Cutting Balloon (P950020/S097) | Boston Scientific Corp | 2020-03-17 |
| VENOUS WALLSTENT (P980033/S050) | Boston Scientific Corporation | 2020-03-17 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCOLAD (N970003/S250) | Boston Scientific Corp | 2020-03-17 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S053) | Beckman Coulter, Inc. | 2020-03-17 |
| Prometra II Programmable Infusion Pump System (P080012/S065) | Infusyn Therapeutics, LLC | 2020-03-17 |
| SICD Gen 2 and SICD MRI (P110042/S135) | Boston Scientific Corporation | 2020-03-17 |
| Precision, Precision Novi, Precision Spectra, Spectra WaveWriter, Precision Montage, and Precision Montage MRI Spinal Co (P030017/S333) | Boston Scientific Corp | 2020-03-17 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S046) | Beckman Coulter, Inc. | 2020-03-17 |
| Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S041) | Beckman Coulter, Inc. | 2020-03-17 |
| NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S172) | Cochlear Americas | 2020-03-17 |
| ORIGEN CRT-D, ORIGEN X4 CRT-D, MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT- (P010012/S517) | Boston Scientific Corp | 2020-03-17 |
| INCRAFT AAA Stent Graft System (P150002/S007) | Cordis US Corporation | 2020-03-17 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, and ACCOLADE MRI EL D (P150012/S091) | Boston Scientific | 2020-03-17 |
| Barricaid Anular Closure Device (ACD) (P160050/S003) | Intrinsic Therapeutics | 2020-03-17 |
| Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S029) | Boston Scientific Corp | 2020-03-17 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S027) | Beckman Coulter, Inc. | 2020-03-17 |
| ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR (P960040/S449) | Boston Scientific | 2020-03-17 |
| VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, and VISIONIST X4 CRT-P (P030005/S196) | Guidant Corp. | 2020-03-17 |
| Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrodes (P070008/S113) | Biotronik, Inc. | 2020-03-16 |
| Gel-One (P080020/S036) | Seikagaku Corp. | 2020-03-16 |
| Optune System (P100034/S023) | Novocure, GmbH | 2020-03-15 |
| Ellipse DR and Ellipse VR (P910023/S426) | ABBOTT MEDICAL | 2020-03-13 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S006) | Berlin Heart, Inc. | 2020-03-13 |
| Alto Abdominal Stent Graft System (P120006/S031) | Endologix, LLC | 2020-03-13 |
| iSert Preloaded IOL System, Intraocular Lens - Clarisert (P080004/S032) | Hoya Surgical Optics, Inc. | 2020-03-12 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S078) | Syncardia Systems, LLC | 2020-03-12 |
| Frequency 55 (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P850079/S086) | CooperVision, Inc. | 2020-03-12 |
| samaritan Public Access Automated External Defibrillators and Accessories (P160008/S010) | Heartsine Technologies, Ltd. | 2020-03-12 |
| XIENCE V Everolimus Eluting Coronary Stent System, XIENCE nano Everolimus Eluting Coronary Stent System (P070015/S147) | Abbott Vascular, Inc. | 2020-03-12 |
| Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S102) | CooperVision, Inc. | 2020-03-12 |
| Cologuard (P130017/S038) | Exact Sciences Corporation | 2020-03-12 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S005) | CooperVision, Inc. | 2020-03-12 |
| XIENCE PRIME SV Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE (P110019/S111) | Abbott Vascular | 2020-03-12 |
| TherOx Downstream System (P170027/S002) | Zoll Circulation, Inc. | 2020-03-11 |
| RHA 2, RHA 3, RHA 4 dermal Fillers (P170002/S008) | Teoxane S.A. | 2020-03-11 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S110) | Edwards Lifesciences, LLC | 2020-03-11 |
| EDWARDS INTUITY Elite Valve System (P150036/S050) | Edwards Lifesciences, LLC | 2020-03-11 |
| LOTUS Edge Valve System (P180029/S021) | Boston Scientific Corporation | 2020-03-11 |
| Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix Tissue Process, Carpentier-Edward (P860057/S199) | Edwards Lifesciences, LLC | 2020-03-11 |
| Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, and Rivacor 5 VR-T (P050023/S143) | Biotronik, Inc. | 2020-03-10 |
| Pulse Generator, Permanent, Implantable (P950037/S206) | Biotronik, Inc. | 2020-03-10 |
| RHA 2, RHA 3, RHA 4 dermal fillers (P170002/S009) | Teoxane S.A. | 2020-03-10 |
| Pulse Generator, Pacemaker, Implantable with cardiac Resynchronization (CRT-D) (P070008/S109) | Biotronik, Inc. | 2020-03-10 |
| Implantable Cardioverter Defibrillator (Non-CRT); Defibrillator, Implantable, Dual-Chamber and Defibrillator, automatic (P050023/S137) | Biotronik, Inc. | 2020-03-10 |
| CINtec PLUS Cytology (P190024) | Ventana Medical Systems, Inc. | 2020-03-10 |
| Sapien 3 Ultra Transcatheter Heart Valve with the Commander Delivery System (P140031/S104) | Edwards Lifesciences, LLC | 2020-03-10 |
| Micra TPS (P150033/S066) | Medtronic, Inc. | 2020-03-06 |
| Platinium CRT-D and Platinium 4LV CRT-D (Cardiac Resynchronization Therapy Defibrillator) (P060027/S102) | MicroPort CRM USA, Inc. | 2020-03-06 |
| 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/S615) | Medtronic, Inc. | 2020-03-06 |
| Evera MRI 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, M (P980016/S729) | Medtronic Cardiac Rhythm Disease Management | 2020-03-06 |
| Attain StarFix Lead (P060039/S099) | Medtronic, Inc. | 2020-03-06 |
| ACE Header, Epicardial Patch Lead (P900061/S157) | Medtronic Cardiac Rhythm Disease Management | 2020-03-06 |
| Attain Ability Lead, Attain Stability Quad MRI Lead (P080006/S146) | Medtronic, Inc. | 2020-03-06 |
| CapSure Epicardial Pacing Lead (P950024/S091) | Medtronic, Inc. | 2020-03-06 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S179) | Medtronic Cardiac Rhythm Disease Management | 2020-03-06 |
| CapSureFix MRI Lead (P090013/S305) | Medtronic, Inc. | 2020-03-06 |
| SelectSecure Lead (P030036/S118) | Medtronic Cardiac Rhythm Disease Management | 2020-03-06 |
| CapSureFix Lead, CapSureFix Novus Lead (P930039/S210) | Medtronic, Inc. | 2020-03-06 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena (P010015/S427) | Medtronic, Inc. | 2020-03-06 |
| Platinium VR and Platinium DR ICDs (Implantable Cardioverter Defibrillator) (P980049/S136) | MicroPort CRM USA, Inc. | 2020-03-06 |
| AMS 800 Series Product Line/Artifical Urinary Sphincter with and without InhibiZone Treatment (P000053/S111) | Boston Scientific Corp | 2020-03-06 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead, Vitatron Brilliant S+VDD Lead (P890003/S426) | Medtronic, Inc. | 2020-03-06 |
| Prestiege LP Cervical Disc - Two-Level (P090029/S013) | Medtronic Sofamor Danek USA, Inc. | 2020-03-06 |
| Y Adapter/Extender Kit, IS-1 Connector Port Pin Plug Kit, Lead Adapter, Sprint Quattro Lead, Transvene CS/SVC Lead (P920015/S242) | Medtronic, Inc. | 2020-03-06 |
| 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/S690) | Medtronic Cardiac Rhythm Disease Management | 2020-03-06 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S175) | Boston Scientific Corp | 2020-03-06 |
| Reply SR and Reply DR Pacemakers (P950029/S124) | MicroPort CRM USA, Inc. | 2020-03-06 |
| Vitatron Impulse II Lead (P850089/S146) | Medtronic Cardiac Rhythm Disease Management | 2020-03-06 |
| PG ADVANTIO DR, PG INGENIO DR, PG VITALIO DR, PG ESSENTIO SR, PG ESSENTIO DR, PG PROPONENT SR, PG PROPONENT DR, PG ACCOL (N970003/S249) | Boston Scientific Corp | 2020-03-05 |
| PG VALITUDE CRT-P, PG VISIONIST CRT-P, and INTUA CRT-P (P030005/S195) | Guidant Corp. | 2020-03-05 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Sphera DR MRI IPG (P980035/S620) | Medtronic, Inc. | 2020-03-05 |
| Wolverine Coronary Cutting Balloon (P950020/S103) | Boston Scientific Corp | 2020-03-05 |
| EDWARDS INTUITY Elite Aortic Valve (P150036/S049) | Edwards Lifesciences, LLC | 2020-03-05 |
| Wolverine Coronary Cutting Balloon (P950020/S104) | Boston Scientific Corp | 2020-03-05 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S108) | Edwards Lifesciences, LLC | 2020-03-05 |
| Carpentier-Edwards PERIMOUNT Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PE (P860057/S198) | Edwards Lifesciences, LLC | 2020-03-05 |
| ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD AUTOGEN VR, ICD AUTOGEN (P960040/S448) | Boston Scientific | 2020-03-05 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards pericardial Mitral Bioprosthesis and Edwards INSPIRIS RESILIA Aortic V (P150048/S044) | Edwards Lifesciences, LLC | 2020-03-05 |
| Artic Front Advance Pro Cardiac Cryoablation Catheters (P100010/S102) | Medtronic Cryocath, LP | 2020-03-05 |
| ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CR (P010012/S516) | Boston Scientific Corp | 2020-03-05 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S070) | Syncardia Systems, LLC | 2020-03-05 |
| S-ICD GEN and S-ICD EMBLEM MRI (P110042/S134) | Boston Scientific Corporation | 2020-03-05 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S109) | Edwards Lifesciences, LLC | 2020-03-05 |
| Sapien 3 Transcatheter Heart Valve and Accessories (P140031/S108) | Edwards Lifesciences, LLC | 2020-03-05 |
| PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, and PG ACCOLADE MR (P150012/S090) | Boston Scientific | 2020-03-05 |
| Therapy Dual 8 Ablation Catheter and Therapy 8mm Thermistor Ablation Catheter (P040042/S044) | Irvine Biomedical,Inc.(Ibi) | 2020-03-04 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S159) | ABBOTT MEDICAL | 2020-03-04 |
| Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S055) | ABBOTT MEDICAL | 2020-03-04 |
| Therapy Cool Path Ablation Catheter (P060019/S046) | Irvine Biomedical, Inc. | 2020-03-04 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S136) | W. L. Gore & Associates, Inc. | 2020-03-04 |