| 13C-Spirulina Gastric Emptying Breath Test (GEBT) (P110015/S005) | Advanced Breath Diagnostics | 2019-08-29 |
| TECNIS iTEC Preloaded Delivery System (P980040/S100) | Johnson & Johnson Surgical Vision, Inc. | 2019-08-29 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S003) | Biotronik AG | 2019-08-29 |
| Durasphere Injectable Bulking Agent (P980053/S017) | Carbon Medical Technologies, Inc. | 2019-08-29 |
| Belotero Balance (+) Lidocaine (P090016/S028) | Merz North America, Inc. | 2019-08-29 |
| Algovita Spinal Cord Stimulation System (P130028/S027) | Nuvectra Corporation | 2019-08-28 |
| Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S085) | Integra Lifesciences Corp. | 2019-08-28 |
| Integra Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template (P900033/S083) | Integra Lifesciences Corp. | 2019-08-28 |
| Therapy Dual-8, Therapy 8mm Thermistor, Safire TX Ablation Catheter (P040042/S043) | Irvine Biomedical,Inc.(Ibi) | 2019-08-28 |
| Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S084) | Integra Lifesciences Corp. | 2019-08-28 |
| Therapy Ablation , Therapy 4mm Thermistor Ablation Catheter (P040014/S037) | Irvine Biomedical, Inc. | 2019-08-28 |
| Ophthalmic Viscoelastic (P000046/S027) | Anika Therapeutics, Inc. | 2019-08-28 |
| Nucleus Auditory Brainstem Implant System (P000015/S039) | Cochlear Americas | 2019-08-27 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG (P980035/S603) | Medtronic, Inc. | 2019-08-27 |
| Juvederm Injectable Gel Implants (Voluma XC, Vollure XC and Volbella XC) (P110033/S048) | Allergan | 2019-08-27 |
| Juvederm Injectable Gel Implants (Ultra, Ultra XC and Ultra Plus XC) (P050047/S072) | Allergan | 2019-08-27 |
| Implantable System for Remodulin (P140032/S039) | Medtronic, Inc. | 2019-08-27 |
| Medtronic Attain Ability Plus Left Ventricular Lead (P080006/S139) | Medtronic, Inc. | 2019-08-27 |
| HiResolution Bionic Ear System (P960058/S142) | Advanced Bionics | 2019-08-27 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S023) | Gen-Probe Incorporated | 2019-08-27 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S417) | Medtronic, Inc. | 2019-08-27 |
| Aptima HPV Assay (P100042/S025) | Gen-Probe Incorporated | 2019-08-27 |
| Nucleus 24 Cochlear Implant System (P970051/S189) | Cochlear Americas | 2019-08-27 |
| Vysis ALK Break Apart FISH Probe Kit (P110012/S019) | Abbott Molecular, Inc. | 2019-08-26 |
| Paradigm Real-Time Revel System (P150019/S058) | Medtronic Minimed | 2019-08-26 |
| AcrySof IQ PanOptix Trifocal Intraocular Lens and AcrySof IQ PanOptix Toric Trifocal Intraocular Lens (P040020/S087) | Alcon Research, Ltd. | 2019-08-26 |
| UroVysion Bladder Cancer Kit (P030052/S026) | Abbott Molecular | 2019-08-26 |
| NeuroPac RNS System (P100026/S074) | NeuroPace, Inc. | 2019-08-26 |
| MiniMed 530G System (P120010/S133) | Medtronic, Inc. | 2019-08-26 |
| CELT ACD Vascular Closure Device (P150006/S004) | Vasorum, Ltd. | 2019-08-26 |
| Guardian Connect System (P160007/S025) | Medtronic Minimed | 2019-08-26 |
| iPro2 CGM System with Enlite Sensor (P150029/S031) | Medtronic Minimed | 2019-08-26 |
| MiniMed 630G System (P150001/S073) | Medtronic Minimed | 2019-08-26 |
| THxID BRAF assay kit (P120014/S009) | bioMerieux, Inc. | 2019-08-26 |
| MiniMed 670G System (P160017/S070) | Medtronic Minimed, Inc. | 2019-08-26 |
| HeartMate 3 Left Ventricular Assist System (P160054/S020) | ABBOTT MEDICAL | 2019-08-25 |
| Percepta/Percepta Quad CRT-P MRI SureScan devices (P010015/S411) | Medtronic, Inc. | 2019-08-23 |
| HeartWare Ventricular Assist System (P100047/S143) | Medtronic | 2019-08-23 |
| Maestro 4000 Controller Firmware (P020025/S121) | Boston Scientific | 2019-08-23 |
| Maestro 4000 Controller Firmware (P920047/S117) | Boston Scientific Corp | 2019-08-23 |
| HiResolution Bionic Ear System (P960058/S141) | Advanced Bionics | 2019-08-23 |
| CoreValve Evolut R System and CoreValve Evolut PRO System (P130021/S062) | Medtronic, Inc. | 2019-08-23 |
| Claria MRI/Claria MRI Quad CRT-D SureScan devices (P010031/S672) | Medtronic Cardiac Rhythm Disease Management | 2019-08-23 |
| Blazer OI, IntellaNav OI, IntellaTip Mifi OI, and IntellaNav Mifi OI Cardiac Ablation Percutaneous Catheter (P150005/S047) | Boston Scientific Corp | 2019-08-23 |
| Maestro 4000 Controller Firmware (P980003/S090) | Boston Scientific Corp | 2019-08-23 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S296) | Medtronic Neuromodulation | 2019-08-22 |
| Sonnet 2 (EAS) Audio Processor and Maestro 8.0 Software (P000025/S112) | Med-El Corp. | 2019-08-22 |
| AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM (P020024/S057) | ABBOTT MEDICAL | 2019-08-22 |
| AMPLATZER PFO OCCLUDER (P120021/S012) | ABBOTT MEDICAL | 2019-08-22 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S441) | Medtronic Neuromodulation | 2019-08-22 |
| AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S037) | ABBOTT MEDICAL | 2019-08-22 |
| THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM (P000039/S067) | ABBOTT MEDICAL | 2019-08-22 |
| TACTICATH QUARTZ SET (P130026/S048) | St Jude Medical | 2019-08-22 |
| AngioSculpt PTCA Scoring Balloon Catheter (P050018/S027) | Spectranetics Corp. | 2019-08-22 |
| Activa Deep Brain Stimulation Therapy System (P960009/S356) | Medtronic, Inc. | 2019-08-22 |
| AED Pro Device (P160022/S012) | ZOLL Medical Corporation | 2019-08-22 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S407) | Medtronic, Inc. | 2019-08-22 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S191) | Medtronic Neuromodulation | 2019-08-22 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S595) | Medtronic, Inc. | 2019-08-22 |
| THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR (P110016/S063) | ABBOTT MEDICAL | 2019-08-22 |
| LIVEWIRE(R) CARDIAC ABLATION SYSTEM (P960016/S079) | St Jude Medical | 2019-08-22 |
| Titan Inflatable Penile Prosthesis (P000006/S052) | Coloplast Corp. | 2019-08-21 |
| PALMAZ Balloon Expandable Stent (P890017/S020) | Cordis US Corporation | 2019-08-21 |
| ATS 3F AORTIC BIOPROSTHESIS MODEL 1000 (P060025/S002) | Medtronic, Inc. | 2019-08-21 |
| iSert Intraocular Lenses (IOLs) (P080004/S024) | Hoya Surgical Optics, Inc. | 2019-08-21 |
| SAPIEN 3 Transcatheter Heart Valve and Accessories (P140031/S091) | Edwards Lifesciences, LLC | 2019-08-21 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S106) | Abbott Vascular, Inc. | 2019-08-21 |
| LOTUS Edge Valve System (P180029/S010) | Boston Scientific Corporation | 2019-08-21 |
| FoundationOne CDx (F1CDx) (P170019/S009) | Foundation Medicine, Inc. | 2019-08-21 |
| Vitatron Software application (P890003/S412) | Medtronic, Inc. | 2019-08-20 |
| Dexcom G4 PLATINUM Continuous Glucose Monitoring System, Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S082) | Dexcom, Inc. | 2019-08-20 |
| Powerheart® G3, G3 Plus and G5 AEDs (P160033/S004) | ZOLL Medical Corporation | 2019-08-20 |
| Implantable System for Remodulin (P140032/S038) | Medtronic, Inc. | 2019-08-20 |
| Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S052) | Boston Scientific Corporation | 2019-08-20 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System Monorail (MR) and Over-The-Wire (OTW) and Prom (P110010/S168) | Boston Scientific Corp | 2019-08-20 |
| Powerheart® G3 Pro AED (P160034/S001) | ZOLL Medical Corporation | 2019-08-20 |
| Adapta, Versa, Sensia IPG, Software application, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, (P980035/S594) | Medtronic, Inc. | 2019-08-20 |
| Obalon Touch Dispenser (P160001/S039) | Medtimo, Inc. | 2019-08-20 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S337) | Medtronic, Inc. | 2019-08-20 |
| Oncomine Dx Target Test (P160045/S016) | Life Technologies Corporation | 2019-08-19 |
| CoreValve Evolut R System and CoreValve Evolut PRO System (P130021/S061) | Medtronic, Inc. | 2019-08-19 |
| Fortify and Fortify Assura ICD Devices (P910023/S417) | ABBOTT MEDICAL | 2019-08-19 |
| AcrySoft Intraocular Lenses (P930014/S125) | Alcon Laboratories, Inc. | 2019-08-19 |
| GEM21S Growth Factor Enhanced Matrix (P040013/S022) | Lynch Biologics, LLC | 2019-08-19 |
| Vercise Gevia DBS System and Directional Lead-only System (P150031/S011) | Boston Scientific Corp | 2019-08-19 |
| Unify, Unify Quadra/Assura and Quadra Assura/MP (P030054/S369) | ABBOTT MEDICAL | 2019-08-19 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S025) | Nevro Corporation | 2019-08-18 |
| SAPIEN 3 Ultra transcatheter heart valve (P140031/S085) | Edwards Lifesciences, LLC | 2019-08-16 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S020) | Medinol, Ltd. | 2019-08-16 |
| Cool Point Irrigation Pump (P060019/S043) | Irvine Biomedical, Inc. | 2019-08-16 |
| AFX Endovascular AAA System (P040002/S063) | Endologix, LLC | 2019-08-16 |
| BAROSTIM NEO® System (P180050) | Cvrx, Inc. | 2019-08-16 |
| Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System (P130021/S058) | Medtronic, Inc. | 2019-08-16 |
| LOTUS Edge Valve System (P180029/S009) | Boston Scientific Corporation | 2019-08-15 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S073) | Syncardia Systems, LLC | 2019-08-15 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S044) | Abbott Diabetes Care, Inc. | 2019-08-15 |
| SAPIEN 3 Transcatheter Heart Valve and Accessories (P140031/S090) | Edwards Lifesciences, LLC | 2019-08-15 |
| LCS(R) Total Knee System (P830055/S234) | Depuy, Inc. | 2019-08-15 |
| Freestyle Libre 14 day Flash Glucose Monitoring System (P160030/S037) | Abbott Diabetes Care, Inc. | 2019-08-15 |
| INCRAFT(R) AAA Stent Graft System (P150002/S006) | Cordis US Corporation | 2019-08-15 |