| EXOSEAL vascular Closure Device (P100013/S020) | Cordis US Corporation | 2019-06-21 |
| S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System (P120002/S016) | Cordis US Corporation | 2019-06-21 |
| Avitene Microfibrillar Collagen Hemostat (MCH) Flour, SyringeAvitene and UltraFoam (N17600/S032) | Davol Inc., Sub. C. R. Bard, Inc. | 2019-06-21 |
| Inspire II Upper Airway Stimulator (P130008/S044) | Inspire Medical Systems | 2019-06-21 |
| Straumann Emdogain (P930021/S023) | The Straumann Company | 2019-06-21 |
| Aptima HCV Quant Dx Assay (P160023/S014) | Hologic, Inc. | 2019-06-21 |
| Accolade MRI Pacemakers (P150012/S079) | Boston Scientific | 2019-06-21 |
| Accolade CRT Pacemakers (CRT-Ps) (P030005/S185) | Guidant Corp. | 2019-06-21 |
| Aptima HCV RNA Qualitative Assay (P020011/S014) | Gen-Probe | 2019-06-21 |
| Incraft (R) AAA Stent Graft System (P150002/S003) | Cordis US Corporation | 2019-06-21 |
| Osteonics ABC/Trident Systems (P000013/S014) | Howmedica Osteonics Corp. | 2019-06-21 |
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and EndoAvitene (P800002/S025) | C.R. Bard, Inc. | 2019-06-21 |
| RESTYLANE NASHA (P040024/S113) | Q-Med AB | 2019-06-20 |
| Freestyle Libre Pro Flash Glucose Monitoring System (P150021/S042) | Abbott Diabetes Care, Inc. | 2019-06-20 |
| RxSight Light Adjustable Lens: Ligh Delivery Device (P160055/S006) | Rxsight, Inc. | 2019-06-20 |
| Guardian Connect System (P160007/S022) | Medtronic Minimed | 2019-06-20 |
| Alinity i Anti-HBc IgM Reagent Kit, Alinity i Anti-HBc IgM Calibrators, Alinity i Anti-HBc IgM Controls (P060035/S026) | Abbott Laboratories | 2019-06-20 |
| MiniMed 670G System (P160017/S065) | Medtronic Minimed, Inc. | 2019-06-20 |
| Dimension FPSA Flex reagent cartridge (P020027/S035) | Siemens Healthcare Diagnostics | 2019-06-20 |
| Freestyle Libre 14 day Flash Glucose Monitoring System (P160030/S035) | Abbott Diabetes Care, Inc. | 2019-06-20 |
| Dimension TPSA Flex reagent cartridge (P000021/S040) | Siemens Healthcare Diagnostics | 2019-06-20 |
| MiniMed 630G System (P150001/S069) | Medtronic Minimed | 2019-06-20 |
| Restylane Injectable Gels (P040024/S111) | Q-Med AB | 2019-06-19 |
| VITROS Anti-HBe (P100001/S016) | Ortho-Clinical Diagnostics | 2019-06-19 |
| Praxis Extended RAS Panel (P160038/S011) | Illumina, Inc. | 2019-06-19 |
| CapSureFix Novus Lead (P930039/S200) | Medtronic, Inc. | 2019-06-19 |
| TactiCath Quartz Contact Force Ablation Catheter (P130026/S047) | St Jude Medical | 2019-06-19 |
| VITROS Anti-HBs (P000014/S035) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| Sprint Quattro Lead (P920015/S230) | Medtronic, Inc. | 2019-06-19 |
| VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S032) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VITROS Anti-HBc IgM (P030026/S036) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VITROS Anti-HBc (P030024/S029) | Ortho-Clinical Diagnostics | 2019-06-19 |
| MarginProbe System (P110014/S008) | Dilon Medical Technologies, Ltd. | 2019-06-19 |
| CapSure Sense Lead (P830061/S171) | Medtronic Cardiac Rhythm Disease Management | 2019-06-19 |
| NeuroPace RNS System (P100026/S066) | NeuroPace, Inc. | 2019-06-19 |
| RELIANCE 4-FRONT Steroid Eluting Leads (P910073/S156) | Boston Scientific | 2019-06-19 |
| LOTUS Edge Valve System (P180029/S006) | Boston Scientific Corporation | 2019-06-19 |
| VITROS HBeAg (P090028/S017) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VITROS HBsAg (P000044/S040) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VenaSeal Closure System (P140018/S015) | Medtronic Vascular, Inc. | 2019-06-19 |
| samaritan Public Access Automated External Defibrillators (P160008/S006) | Heartsine Technologies, Ltd. | 2019-06-19 |
| Express SD Premounted Stent System (ESD) (P060006/S096) | Boston Scientific Corp | 2019-06-18 |
| Innova Vasculaar Self-Expanding Stent System (P140028/S040) | Boston Scientific Corporation | 2019-06-18 |
| REBEL Plantinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P130030/S060) | Boston Scientific Corp | 2019-06-18 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S008) | Boston Scientific Corp | 2019-06-18 |
| PhysioStim and SpinalStim (P850007/S041) | Orthofix, Inc. | 2019-06-18 |
| AIA-PACK PSA (P910065/S009) | Tosoh Bioscience, Inc. | 2019-06-18 |
| Express LD Premounted Iliac Stent System (ELD) (P090003/S047) | Boston Scientific Corporation | 2019-06-18 |
| Epic Vascular Self-Expanding Stent System (P110035/S050) | Boston Scientific Corp | 2019-06-18 |
| Synergy Everolimus-Eluting Platinum Chromium Coronaray Stent System (P150003/S047) | Boston Scientific Corporation | 2019-06-18 |
| CervicalStim (P030034/S014) | Orthofix, Inc. | 2019-06-18 |
| Prometra Programmable Infusion Pump System (P080012/S049) | Infusyn Therapeutics, LLC | 2019-06-18 |
| PROMUS Element Plus Everolimus-Eluting Plaatinum Chromium Coronary Stent System (Monorail and Over-the-Wire), PROMUS PRE (P110010/S165) | Boston Scientific Corp | 2019-06-18 |
| Alinity i Anti-HCV Reagent Kit, Alinity i Anti-HCV Calibrator, Alinity i Anti-HCV Controls (P050042/S034) | Abbott Laboratories, Inc. | 2019-06-18 |
| Belotero Balance (P090016/S032) | Merz North America, Inc. | 2019-06-18 |
| Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI Cardiac Ablation Percutaneous Catheter (P150005/S045) | Boston Scientific Corp | 2019-06-17 |
| NeuroPace RNS System (P100026/S071) | NeuroPace, Inc. | 2019-06-17 |
| Protégé GPS and Protégé RX Carotid Stent Systems, and Protégé GPS Peripheral Stent Systems (P060001/S028) | Medtronic Vascular, Inc. | 2019-06-17 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S095) | Medtronic Cryocath, LP | 2019-06-17 |
| Blazer II, Blazer II HTD, Blazer II XP, Blazer Prime HTD, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav MiFi XP, Intel (P020025/S120) | Boston Scientific | 2019-06-17 |
| EverFlex Self-Expanding Peripheral Stent Systems and EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syst (P110023/S027) | Medtronic Vascular, Inc. | 2019-06-17 |
| Blazer II XP, Blazer Prime HTD, Blazer Prime XP Cardiac Ablation Percutaneous Catheter (P920047/S116) | Boston Scientific Corp | 2019-06-17 |
| Onyx Liquid Embolic System (P030004/S019) | Ev3 Neurovascular | 2019-06-17 |
| HEMOBLAST Bellows (P170012/S018) | Dilon Technologies, Inc. | 2019-06-15 |
| SynchroMed Infusion System, Ascends Intrathecal Catheters (P860004/S316) | Medtronic, Inc. | 2019-06-14 |
| Activa Deep Brain Stimulation Therapy System (P960009/S322) | Medtronic, Inc. | 2019-06-14 |
| Implantable System for Remodulin (P140032/S018) | Medtronic, Inc. | 2019-06-14 |
| Collastat Absorbable Collagen Hemostatic Sponge (P810006/S083) | Integra LifeSciences Corporation | 2019-06-14 |
| LifePulse High Frequency Ventilator (P850064/S039) | Bunnell, Inc. | 2019-06-14 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S166) | Boston Scientific Corp | 2019-06-14 |
| Minimed 630G System with SmartGuard (P150001/S068) | Medtronic Minimed | 2019-06-14 |
| Cochlear Nucleus CI600 Series Cochlear Implants (P970051/S183) | Cochlear Americas | 2019-06-14 |
| MiniMed 670G System (P160017/S064) | Medtronic Minimed, Inc. | 2019-06-14 |
| CollaCote and CollaTape Absorbable Collagen Wond Dressing for Dental Surgery (P840062/S069) | Integra Lifesciences Corp. | 2019-06-14 |
| AEGEA Vapor System, Aegea Vapor Probe Procedure Kit, Aegea Vapor Generator and Aegea Vapor Generator Accessory Kit (P160047/S004) | CooperSurgical, Inc. | 2019-06-14 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation System and Pisces, Specify and Vectris Sprinal Cord Stimula (P840001/S405) | Medtronic Neuromodulation | 2019-06-14 |
| Guardian Connect System (P160007/S021) | Medtronic Minimed | 2019-06-14 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S049) | Boston Scientific Corporation | 2019-06-14 |
| Helistat Absorbable Collagen Hemostatic Agent (P850010/S083) | Integra LifeSciences Corporation | 2019-06-14 |
| Parvovirus B19 IgG Enzyme Immunoassay (V519IGUS) (P970054/S015) | Diasorin | 2019-06-13 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivey System (P130013/S029) | Boston Scientific Corp | 2019-06-13 |
| Cologuard (P130017/S031) | Exact Sciences Corporation | 2019-06-13 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 (P060030/S077) | Roche Molecular Systems, Inc. | 2019-06-13 |
| Parvovirus B19 IgM Enzyme Immunoassay (V619IMUS) (P970055/S017) | Diasorin | 2019-06-13 |
| LCS Total Knee System (P830055/S232) | Depuy, Inc. | 2019-06-13 |
| TactiSys Quartz System (P130026/S046) | St Jude Medical | 2019-06-13 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S023) | Abbott Vascular (Idef Technologies Inc) | 2019-06-13 |
| Vistakon (senofilcon A) Brand Contact Lenses (P040045/S109) | Vistakon, Division of Johnson & Johnson Vision Car | 2019-06-12 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S425) | Medtronic Neuromodulation | 2019-06-12 |
| Edwards Pericradial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve (P150048/S035) | Edwards Lifesciences, LLC | 2019-06-12 |
| Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (P160049/S006) | The Spectranetics Corp. | 2019-06-12 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S048) | Boston Scientific Corporation | 2019-06-11 |
| CareLink SmartSync Percepta Serena Solara Application; Percepta, Serena, Solara Quard CRT-P MRI SureScan. (P010015/S399) | Medtronic, Inc. | 2019-06-11 |
| CareLink SmartSync Host, Platform, Common Application (P890003/S407) | Medtronic, Inc. | 2019-06-11 |
| Evera MRI, Evera, Marquis, Secura Maximo II, Intrinsic, Protecta, Protecta XT, Virtuoso II, Visia AF (P980016/S702) | Medtronic Cardiac Rhythm Disease Management | 2019-06-11 |
| Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S190) | Edwards Lifesciences, LLC | 2019-06-11 |
| AUGMENT Injectable (P100006/S008) | Biomimetic Therapeutics, LLC | 2019-06-11 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S400) | Medtronic, Inc. | 2019-06-11 |
| Angio Seal Vascular Closure Devices (P930038/S096) | Terumo Medical Corporation | 2019-06-11 |
| Edwards Sapien 3 Transcatheter Heart Valve and Sapien 3 Ultra Transcatheter Heart Valve (P140031/S089) | Edwards Lifesciences, LLC | 2019-06-11 |