| Mobi-C Cervical Disc Prosthesis (P110002/S023) | Highridge Medical, LLC | 2020-02-18 |
| LifePulse High Frequency Ventilator (P850064/S040) | Bunnell, Inc. | 2020-02-14 |
| ocufilcon D soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S042) | The Cooper Companies | 2020-02-14 |
| Aptima HBV Quant Assay (P170025/S015) | Hologic, Inc. | 2020-02-14 |
| Nucleus CI624 Implant System (P970051/S191) | Cochlear Americas | 2020-02-14 |
| Aptima HCV Quant Dx Assay (P160023/S017) | Hologic, Inc. | 2020-02-14 |
| iDESIGN Refractive Studio (P930016/S061) | Amo Manufacturing USA, LLC | 2020-02-14 |
| Aptima HCV RNA Qualitative Assay (P020011/S015) | Gen-Probe | 2020-02-14 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S027) | Medtronic Vascular | 2020-02-14 |
| Xience Sierra Everolimus Eluting Coronary Stent System (P110019/S110) | Abbott Vascular | 2020-02-13 |
| AMS 800 Artificial Urinary Sphincter with InhibiZone (P000053/S104) | Boston Scientific Corp | 2020-02-13 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S014) | Physio-Control, Inc. | 2020-02-13 |
| Relay Thoracic Stent-Graft with Plus Delivery System (P110038/S021) | Bolton Medical, Inc. | 2020-02-13 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S187) | Medtronic Neuromodulation | 2020-02-13 |
| AMS 700 Inflatable Penile Prosthesis (N970012/S163) | Boston Scientific Corp | 2020-02-13 |
| ORBERA Intragastric Balloon System (P140008/S016) | Boston Scientific Corporation | 2020-02-13 |
| Algovita Spinal Cord Stimulation System (P130028/S028) | Nuvectra Corporation | 2020-02-12 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S023) | Boston Scientific Corp | 2020-02-12 |
| Trocar Knife (P870076/S024) | Gyrus Acmi, Inc. | 2020-02-12 |
| Minerva Endometrial Ablation System (P140013/S011) | Axora Medical, Inc. | 2020-02-12 |
| Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (P160049/S008) | The Spectranetics Corp. | 2020-02-11 |
| Obalon Ballon System with Navigation and Touch (P160001/S044) | Medtimo, Inc. | 2020-02-11 |
| Aptima HPV Assay (P100042/S029) | Gen-Probe Incorporated | 2020-02-10 |
| Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve (P150011/S018) | Corcym S.r.l. | 2020-02-10 |
| Solo Smart Heart Valve (P130011/S008) | Corcym Canada Corp | 2020-02-10 |
| Cartiva Synthetic Cartilage Implant (Cartiva SCI) (P150017/S013) | Cartiva, Inc. | 2020-02-09 |
| Blazer Prime XP and IntellaTip MiFi XP (P020025/S124) | Boston Scientific | 2020-02-07 |
| Zilver Vascular Stent (P050017/S018) | Cook Ireland, Ltd. | 2020-02-07 |
| 3000 Series Implantable Infusion Pump and the MedStream Programmable Infusion System and Accessories (P890055/S073) | Intera Oncology | 2020-02-07 |
| Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S003) | MicroVention, Inc. | 2020-02-07 |
| INFUSAID Implantable Infusion Pump and Accessories (P800036/S041) | Intera Oncology | 2020-02-07 |
| Blazer Prime HTD (P920047/S120) | Boston Scientific Corp | 2020-02-07 |
| Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler (P090016/S038) | Merz North America, Inc. | 2020-02-07 |
| cobas CMV (P160041/S028) | Roche Molecular Systems, Inc. | 2020-02-06 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S022) | Boston Scientific Corp | 2020-02-06 |
| cobas HBV (P150014/S035) | Roche Molecular Systems, Inc. | 2020-02-06 |
| Promus Element Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus Premier Everolimus-Eluting Platinum Ch (P110010/S174) | Boston Scientific Corp | 2020-02-06 |
| Belotero Balance Dermal Filler (P090016/S035) | Merz North America, Inc. | 2020-02-06 |
| cobas HCV (P150015/S037) | Roche Molecular Systems, Inc. | 2020-02-06 |
| Activa Deep Brain Stimulation Therapy System (P960009/S368) | Medtronic, Inc. | 2020-02-05 |
| CardioMEMS HF System (P100045/S041) | ABBOTT MEDICAL | 2020-02-05 |
| Infuse Bone Graft (P050053/S045) | Medtronic, Inc. | 2020-02-05 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S307) | Medtronic Neuromodulation | 2020-02-05 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S001) | CooperVision, Inc. | 2020-02-05 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S166) | W. L. Gore & Associates, Inc. | 2020-02-05 |
| Storz Medical Duolith SD1 Shock Wave Therapy Device (P080028/S001) | Storz Medical AG | 2020-02-05 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S453) | Medtronic Neuromodulation | 2020-02-05 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S202) | Medtronic Neuromodulation | 2020-02-05 |
| Belotero Balance Dermal Filler, Belotero Balance (+) Lidocaine Dermal Filler (P090016/S036) | Merz North America, Inc. | 2020-02-04 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses (P180035/S002) | CooperVision, Inc. | 2020-02-04 |
| CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S021) | Ceramtec GmbH | 2020-02-04 |
| CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S209) | Medtronic, Inc. | 2020-02-04 |
| Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S073) | Medtronic Sofamor Danek USA, Inc. | 2020-02-04 |
| Infuse Bone Graft (P000054/S054) | Medtronic Sofamor Danek USA, Inc. | 2020-02-04 |
| Medtronic SelectSecure MRI SureScan Lead (P030036/S117) | Medtronic Cardiac Rhythm Disease Management | 2020-02-03 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S101) | Medtronic Cryocath, LP | 2020-02-03 |
| Freezor, Arctic Front Advance (AFA) CryoAblation Catheters (P020045/S093) | Medtronic Cryocath, LP | 2020-02-03 |
| SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S346) | Medtronic, Inc. | 2020-02-03 |
| Mosaic Bioprosthesis (P990064/S081) | Medtronic, Inc. | 2020-02-02 |
| Medtronic MiniMed 630G System (P150001/S082) | Medtronic Minimed | 2020-01-31 |
| Aesculap activL Artificial Disc (P120024/S011) | Highridge Medical, LLC | 2020-01-31 |
| VNS Therapy System (P970003/S228) | LivaNova USA, Inc. | 2020-01-31 |
| Guardian Connect System (P160007/S034) | Medtronic Minimed | 2020-01-31 |
| Medtronic MiniMed 670G System (P160017/S081) | Medtronic Minimed, Inc. | 2020-01-31 |
| M6-C Artificial Cervical Disc (P170036/S004) | Spinal Kinetics, LLC | 2020-01-31 |
| RHA 2, RHA 3, RHA 4 (P170002/S006) | Teoxane S.A. | 2020-01-30 |
| Rotapro Rotational Atherectomy System (P900056/S181) | Boston Scientific Corp | 2020-01-30 |
| Axonics Sacral Neuromodulation (SNM) System (P180046/S003) | Boston Scientific Corporation | 2020-01-30 |
| Automated Impella Controller (P170011/S015) | Abiomed, Inc. | 2020-01-30 |
| Automated Impella Controller (P140003/S057) | Abiomed, Inc. | 2020-01-30 |
| Gynecare Interceed Absorbable Adhesion Barrier (P880047/S034) | ETHICON, Inc. | 2020-01-30 |
| Drug Eluting Permanent Right Venticular/Right Atrial Pacemaker Electrodes, Stylets, Stylet, Catheter, Blind Plug, Perman (P950037/S209) | Biotronik, Inc. | 2020-01-29 |
| Gore Viatorr Tips Endoprosthesis and Gore Viatorr Tips Endoprosthesis with Controlled Expansion (P040027/S077) | W. L. Gore & Associates, Inc. | 2020-01-29 |
| Activa Deep Brain Stimulation Therapy System (P960009/S363) | Medtronic, Inc. | 2020-01-29 |
| Stylet Catheter, Implantable Cardioverter Defibrillator, Implantable Dual-Chamber Defibrillator, Defibrillator Automatic (P050023/S141) | Biotronik, Inc. | 2020-01-29 |
| Drug Eluting Permanent Left Ventricular Pacemaker Electrode, Pulse Generator Pacemaker Implantable with Cardiac Resynchr (P070008/S111) | Biotronik, Inc. | 2020-01-29 |
| Permanent Defibrillator Electrodes, Accessories to Permanent Pacemaker Electrode, Stylet Catheter (P980023/S097) | Biotronik, Inc. | 2020-01-29 |
| VNS Therapy System (P970003/S230) | LivaNova USA, Inc. | 2020-01-29 |
| PG ESSENTIO SR/DR SL, PG PROPONENT SR/DR SL, DR EL, PG ACCOLADE SR/DR SL, DR EL, PG ALTRUA 2 SR/DR SL, DR EL (N970003/S248) | Boston Scientific Corp | 2020-01-28 |
| PG VALITUDE CRT-P IS1 EL, IS4 EL, PG VISIONIST CRT-P IS1 EL, LV1 EL, IS4 EL (P030005/S194) | Guidant Corp. | 2020-01-28 |
| PG ESSENTION MRI SR/DR SL, PG ESSENTIO DR EL, PG ESSENTIO MRI DR EL, PG PROPONENT MRI SR/DR/ SL, PG PROPONENT MRI DR EL, (P150012/S089) | Boston Scientific | 2020-01-28 |
| Pearle Vision Monthly Multifocal (P080011/S098) | CooperVision, Inc. | 2020-01-28 |
| ICD ORIGEN CRT-D DF4/IS1, DF/IS1/ DF1/IS1/IS4, AND DF4/IS1/IS4, MMENTUM CRT-D IS1 DF4 IS1 (P010012/S515) | Boston Scientific Corp | 2020-01-28 |
| Bulkamid Urethral Bulking System (P170023) | Boston Scientific Corporation | 2020-01-28 |
| Axonics Sacral Neuromodulation (SNM) System (P190006/S003) | Boston Scientific Corporation | 2020-01-28 |
| Rapid fFN for the TLiIQ System, Fetal Fibronectin Enzyme Immunoassay (P920048/S013) | Hologic, Inc. | 2020-01-28 |
| iDESIGN Refractive Studio (P930016/S060) | Amo Manufacturing USA, LLC | 2020-01-28 |
| Sprint Quattro Lead (P920015/S241) | Medtronic, Inc. | 2020-01-28 |
| Tack Endovascular System (6F) (P180034/S001) | Philips Image Guided Therapy Corporation | 2020-01-28 |
| ICE ORIGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD INOGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD DYNAGE (P960040/S447) | Boston Scientific | 2020-01-28 |
| HeartMate 3 Left Ventricular Assist System (P160054/S021) | ABBOTT MEDICAL | 2020-01-27 |
| IntellaNav MiFi XP amd IntellaNav XP (P020025/S123) | Boston Scientific | 2020-01-27 |
| IntellaNav OI and IntellaNav MiFi OI (P150005/S051) | Boston Scientific Corp | 2020-01-27 |
| HeartWare HVAD System (P100047/S150) | Medtronic | 2020-01-27 |
| IntellaNav ST (P920047/S119) | Boston Scientific Corp | 2020-01-27 |
| HeartMate II Left Ventricular Assist System (P060040/S073) | ABBOTT MEDICAL | 2020-01-27 |
| VenaSeal Closure System (P140018/S018) | Medtronic Vascular, Inc. | 2020-01-25 |
| AED Plus (P160015/S003) | ZOLL Medical Corporation | 2020-01-24 |
| HEMOBLAST Bellows (P170012/S021) | Dilon Technologies, Inc. | 2020-01-24 |
| Praxis Extended RAS Panel (P160038/S015) | Illumina, Inc. | 2020-01-24 |