| HiResolution Bionic Ear System (P960058/S146) | Advanced Bionics | 2019-12-17 |
| Biofinity (comfilcon A) Toric Multifocal Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S100) | CooperVision, Inc. | 2019-12-17 |
| LOTUS Edge Valve System (P180029/S018) | Boston Scientific Corporation | 2019-12-17 |
| Freestyle Libre 14-day Flash Glucose Monitoring System (P160030/S040) | Abbott Diabetes Care, Inc. | 2019-12-16 |
| EMBLEM S-ICD Automated Screening Tool (P110042/S129) | Boston Scientific Corporation | 2019-12-16 |
| FoundationOne CDx (F1CDx) (P170019/S010) | Foundation Medicine, Inc. | 2019-12-16 |
| Brava CRT-D, Brava Quad CRT-D, Viva Quad CRT-D, Viva Quad S/XT CRT-D, and Viva S/XT CRT-D (P010031/S683) | Medtronic Cardiac Rhythm Disease Management | 2019-12-16 |
| Flow Re-Direction Endoluminal Device (FRED®) System (P180027) | MicroVention, Inc. | 2019-12-16 |
| Evera S DR/VR ICd, Evera XT DR/VR ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Mirro MRI DR/VR ICD, and Primo MRI DR/VR ICD (P980016/S722) | Medtronic Cardiac Rhythm Disease Management | 2019-12-16 |
| Multiple Application Utility (MAU) and Data Management System (DM) LATITUDE Programming System )LPS) (P910077/S174) | Boston Scientific | 2019-12-16 |
| X Series®/Propaq MD device (P160022/S008) | ZOLL Medical Corporation | 2019-12-16 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S047) | Abbott Diabetes Care, Inc. | 2019-12-16 |
| Perceval Sutureless Heart Valve (P150011/S017) | Corcym S.r.l. | 2019-12-16 |
| INGEVITY (P150012/S085) | Boston Scientific | 2019-12-16 |
| Ingevity + Lead - Active Fixation (P150012/S083) | Boston Scientific | 2019-12-16 |
| Aptima HCV Quant Dx Assay (P160023/S015) | Hologic, Inc. | 2019-12-16 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S022) | Gen-Probe Incorporated | 2019-12-16 |
| Infuse Bone Graft (P050053/S046) | Medtronic, Inc. | 2019-12-16 |
| Aptima HBV Quant Assay (P170025/S013) | Hologic, Inc. | 2019-12-16 |
| TactiCath Quartz Contact Force Ablation Catheter (TactiCath Quartz) (P130026/S054) | St Jude Medical | 2019-12-16 |
| Aptima HPV Assay (P100042/S024) | Gen-Probe Incorporated | 2019-12-16 |
| Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S074) | Medtronic Sofamor Danek USA, Inc. | 2019-12-13 |
| Bellafill Dermal Filler (P020012/S033) | Tiger Aesthetics Medical, LLC | 2019-12-13 |
| WaveLight EX500 Laser System/Allegro Topolyzer Vario (P030008/S030) | Alcon Laboratories, Inc. | 2019-12-13 |
| MULTI-LINK ULTRA RX Coronary Stent System (P970020/S084) | Abbott Vascular, Inc. | 2019-12-13 |
| CapSure Epicardial Pacing Lead (P950024/S089) | Medtronic, Inc. | 2019-12-13 |
| Attain Ability Lead (P080006/S142) | Medtronic, Inc. | 2019-12-13 |
| Attain StarFix Lead (P060039/S097) | Medtronic, Inc. | 2019-12-13 |
| Sprint Quattro Lead; Subcutaneous Lead; Transvene CS/SVC Lead (P920015/S238) | Medtronic, Inc. | 2019-12-13 |
| SelectSure Lead (P030036/S114) | Medtronic Cardiac Rhythm Disease Management | 2019-12-13 |
| AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S173) | Boston Scientific Corp | 2019-12-13 |
| Hydrus Microstent (P170034/S003) | Alcon Research, LLC | 2019-12-13 |
| CapSure Sense Lead; Vitatron Crystalline Lead (P830061/S176) | Medtronic Cardiac Rhythm Disease Management | 2019-12-13 |
| Transvene CS-SVC Lead (P980050/S123) | Medtronic, Inc. | 2019-12-13 |
| WaveLight EX500 Laser System/Allegro Topolyzer Vario (P020050/S034) | Alcon Laboratories, Inc. | 2019-12-13 |
| Nucleus 24 Cochlear Implant System (P970051/S194) | Cochlear Americas | 2019-12-13 |
| CapSureFix Novus Lead; Vitatron Crystalline Active Fixation Lead (P930039/S206) | Medtronic, Inc. | 2019-12-13 |
| Nucleus ABI541 Auditory Brainstem Implant (P000015/S042) | Cochlear Americas | 2019-12-13 |
| LifePulse High Frequency Ventilator (P850064/S042) | Bunnell, Inc. | 2019-12-13 |
| Infuse Bone Graft (P000054/S055) | Medtronic Sofamor Danek USA, Inc. | 2019-12-13 |
| CapSure VDD-2 Lead; Vitatron Brilliant S+ VDD Lead (P890003/S421) | Medtronic, Inc. | 2019-12-13 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S021) | Boston Scientific Corp | 2019-12-13 |
| RHA2, RHA3, and RHA4 dermal fillers (P170002/S007) | Teoxane S.A. | 2019-12-13 |
| Innova Vascular Self-Expanding Stent System (P140028/S052) | Boston Scientific Corporation | 2019-12-13 |
| Angio-Seal Vascular Closure Devices (P930038/S097) | Terumo Medical Corporation | 2019-12-13 |
| Axonics Sacral Neuromodulation System (P190006/S002) | Boston Scientific Corporation | 2019-12-12 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S034) | Boston Scientific Corp | 2019-12-12 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone (N970012/S171) | Boston Scientific Corp | 2019-12-12 |
| Lotrafilcon B soft contact lenses for extended wear (P010019/S074) | Alcon Laboratories, Inc. | 2019-12-12 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S198) | Medtronic Neuromodulation | 2019-12-11 |
| Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S448) | Medtronic Neuromodulation | 2019-12-11 |
| Implantable System for Remodulin (P140032/S043) | Medtronic, Inc. | 2019-12-11 |
| Lotus Edge Valve System (P180029/S019) | Boston Scientific Corporation | 2019-12-11 |
| Cobas HBV (P150014/S030) | Roche Molecular Systems, Inc. | 2019-12-11 |
| PRISMAFLEX TPE2000 (P830063/S014) | Vantive US Healthcare, LLC | 2019-12-11 |
| SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S347) | Medtronic, Inc. | 2019-12-11 |
| AMS 800 Artificial Urinary Sphincter (P000053/S110) | Boston Scientific Corp | 2019-12-11 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone, AMS Ambicor IPP (N970012/S172) | Boston Scientific Corp | 2019-12-11 |
| Activa Deep Brain Stimulation Therapy System (P960009/S362) | Medtronic, Inc. | 2019-12-11 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S303) | Medtronic Neuromodulation | 2019-12-11 |
| Cobas CMV (P160041/S023) | Roche Molecular Systems, Inc. | 2019-12-11 |
| Cobas HCV (P150015/S032) | Roche Molecular Systems, Inc. | 2019-12-11 |
| Micra TPS (P150033/S062) | Medtronic, Inc. | 2019-12-10 |
| Hancock II Bioprosthesis (P980043/S072) | Medtronic, Inc. | 2019-12-10 |
| Advisa DR, Advisa DR MRI, Advisa SR MRI, Astra S DR MRI, Astra S SR MRI, Asrtra XT DR MRI, Astra XT SR MRI, Azure S DR (P980035/S608) | Medtronic, Inc. | 2019-12-10 |
| Arctic Front Advance and Arctic Front Advance Pro (P100010/S099) | Medtronic Cryocath, LP | 2019-12-10 |
| EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems of the Evolut R/PRO/PRO+ Systems (P130021/S069) | Medtronic, Inc. | 2019-12-10 |
| Apollo Onyx Delivery Microcatheter (P030004/S021) | Ev3 Neurovascular | 2019-12-10 |
| MAMMOMAT Revelation with Tomosynthesis Option (P140011/S006) | Siemens Medical Solutions USA, Inc. | 2019-12-10 |
| Hydrus Microstent (P170034/S002) | Alcon Research, LLC | 2019-12-10 |
| Pipeline Flex Embolization Device (P100018/S022) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2019-12-10 |
| Avalus (P170006/S016) | Medtronic, Inc. | 2019-12-10 |
| Hancock Valved Conduit Modified Orifice (P790007/S062) | Medtronic Heart Valves | 2019-12-10 |
| Evolut R and Evolut PRO (P130021/S064) | Medtronic, Inc. | 2019-12-10 |
| Melody (P140017/S016) | Medtronic, Inc. | 2019-12-10 |
| Freestyle Bioprosthesis (P970031/S067) | Medtronic, Inc. | 2019-12-10 |
| Attain Ability Leads, Attain Performa Leads, Attains Stability Quad MRI Lead (P080006/S144) | Medtronic, Inc. | 2019-12-10 |
| Linx Reflux Management System (P100049/S028) | Torax Medical | 2019-12-10 |
| Evera MRI DF-1, Evera MRI, Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Mirro MRI DR, Mirro MRI VR, Primo MRI DR, P (P980016/S723) | Medtronic Cardiac Rhythm Disease Management | 2019-12-10 |
| Hancock Valved Conduit Low Porosity (P870078/S047) | Medtronic, Inc. | 2019-12-10 |
| Mosaic Bioprosthesis (P990064/S080) | Medtronic, Inc. | 2019-12-10 |
| Amplia MRI, Amplia MRI Quad, Brava, Brava Quad, Claria MRI, Claria MRI Quad, Compia MRI, Compia MRI Quad, Consulta, Prot (P010031/S684) | Medtronic Cardiac Rhythm Disease Management | 2019-12-10 |
| Consulta, Percepta Bipolar, Percepta Quadripolar, Serena Bipolar, Serena Quadripolar, Solara Bipolar, Solara Quadripolar (P010015/S421) | Medtronic, Inc. | 2019-12-10 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030/S129) | Zoll Manufacturing Corporation | 2019-12-09 |
| Gore Excluder AAA Endoprosthesis (P020004/S167) | W. L. Gore & Associates, Inc. | 2019-12-09 |
| LUTONIX® 035 Drug Coated Balloon PTA Catheter (P170003/S011) | Lutonix | 2019-12-09 |
| Lotus Edge Valve System (P180029/S003) | Boston Scientific Corporation | 2019-12-06 |
| CentriMag Circulatory Support System (P170038) | Abbott | 2019-12-06 |
| GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Conrolled Expansion (P040027/S075) | W. L. Gore & Associates, Inc. | 2019-12-06 |
| AUGMENT Bone Graft and AUGMENT Injectable (P100006/S011) | Biomimetic Therapeutics, LLC | 2019-12-06 |
| Assurity MRI and Endurity MRI Pacemakers (P140033/S051) | ABBOTT MEDICAL | 2019-12-06 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S012) | Celonova Biosciences, Inc. | 2019-12-06 |
| Endurity, Endurity Core, Assurity and Assurity + (P880086/S309) | ABBOTT MEDICAL | 2019-12-06 |
| BD FocalPoint GS Imaging System (P950009/S023) | Bd Diagnostics | 2019-12-06 |
| Zephyr Endobronchial Valve (EBV) System (P180002/S014) | Pulmonx Corporation | 2019-12-06 |
| QuantiFERON TB Gold and QuantiFERON-TB Gold Plus (P010033/S046) | Qiagen | 2019-12-06 |
| ACUITY X4 Electrode 2, 3, and (E24) (P010012/S512) | Boston Scientific Corp | 2019-12-06 |
| prodisc L (P050010/S022) | Centinel Spine, LLC | 2019-12-05 |
| Precision, Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage, and Precision Montage MRI Spinal Co (P030017/S332) | Boston Scientific Corp | 2019-12-05 |
| LifeVest Wearable Defibrillator (P010030/S127) | Zoll Manufacturing Corporation | 2019-12-05 |