| CyPass System, CyPass Ultra System, CyPass Micro-Stent (P150037/S011) | Alcon Research, Ltd. | 2018-08-13 |
| RADIESSE 0.8cc and 1.5cc (P050037/S089) | Merz North America, Inc. | 2018-08-12 |
| CoreValve Evolut R System, CoreValve Evolut R XL System and CoreValve Evolut PRO System (P130021/S052) | Medtronic, Inc. | 2018-08-12 |
| RADIESSE (+) Lidocaine 0.8cc and 1.5cc (P050052/S105) | Merz North America, Inc. | 2018-08-12 |
| Protecta CRT-D, Protecta XT CRT-D (P010031/S637) | Medtronic Cardiac Rhythm Disease Management | 2018-08-10 |
| CryoConsole (P020045/S089) | Medtronic Cryocath, LP | 2018-08-10 |
| activL Artificial Disc (P120024/S007) | Highridge Medical, LLC | 2018-08-10 |
| HeartWare Ventricular Assist System (P100047/S126) | Medtronic | 2018-08-10 |
| TRIDYNE VASCULAR SEALANT; TRIDYNE VS Standard Spray Tips; TRIDYNE VS 6 Extended Spray Tip (P150016/S009) | Neomend, Inc. | 2018-08-10 |
| Impella RP (P170011/S006) | Abiomed, Inc. | 2018-08-10 |
| Integra Dermal Regeneration Template (P900033/S072) | Integra Lifesciences Corp. | 2018-08-10 |
| MED-EL Cochlear Implant System (P000025/S102) | Med-El Corp. | 2018-08-10 |
| Protecta ICD, Protecta VR/XT ICD (P980016/S677) | Medtronic Cardiac Rhythm Disease Management | 2018-08-10 |
| HYDRUS MICROSTENT (P170034) | Alcon Research, LLC | 2018-08-10 |
| 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/S639) | Medtronic Cardiac Rhythm Disease Management | 2018-08-10 |
| 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/S680) | Medtronic Cardiac Rhythm Disease Management | 2018-08-10 |
| DBS System 4CH Lead / DBS System 8CH Directional Lead (P140009/S036) | ABBOTT MEDICAL | 2018-08-10 |
| S 75-G OTW; S 75-K OTW; S 85-G OTW; S 85-K OTW (P050023/S122) | Biotronik, Inc. | 2018-08-09 |
| EXOSEAL Vascular Closure Device (P100013/S017) | Cordis US Corporation | 2018-08-09 |
| EFH-16; S60-K; S 60-J; S 60-S (P820076/S028) | Biotronik, Inc. | 2018-08-09 |
| Corox OTW BP; Corox OTW-L BP; Corox ProMRI OTW BP; Sentus ProMRI OTW QP S; Sentus ProMRI OTW QP S-xx/49; Corox OTW-S BP; (P070008/S095) | Biotronik, Inc. | 2018-08-09 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M (P150048/S012) | Edwards Lifesciences, LLC | 2018-08-09 |
| WaveLight EX500 Laser System with Patient Bed Swivel 1125 (P030008/S026) | Alcon Laboratories, Inc. | 2018-08-09 |
| AFX Endovascular AAA System (P040002/S061) | Endologix, LLC | 2018-08-09 |
| Astron Pulsar/Pulsar-18 Stent Systems (P160025/S006) | Biotronik AG | 2018-08-09 |
| Protego SD; Protego TD; Protego DF-1 SD; Protego ProMRI SDx; Protego DF-1; ProMRI SD; Plexa SD; Plexa ProMRI SD; Plexa D (P980023/S086) | Biotronik, Inc. | 2018-08-09 |
| WaveLight EX500 Laser System with Patient Bed Swivel 1125 (P020050/S030) | Alcon Laboratories, Inc. | 2018-08-09 |
| ARCHITECT CORE, LN 6L22 (P080023/S029) | Abbott Laboratories | 2018-08-09 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S005) | Bard Peripheral Vascular, Inc. | 2018-08-09 |
| Biofinity Sphere and Biofinity XR Sphere, Biofinity Energys; Biofinity Toric and Biofinity XR Toric; Biofinity Multifoca (P080011/S078) | CooperVision, Inc. | 2018-08-09 |
| Selox ST/JT; Siello S; Solia S; Setrox S; Safio S; S 45-K/53-K; DH; DH IS-1/DF4; EFH-6F-W; S53-K; S 45-S; S 53-S; S 45-F (P950037/S193) | Biotronik, Inc. | 2018-08-09 |
| HEMOBLAST Bellows (P170012/S008) | Dilon Technologies, Inc. | 2018-08-08 |
| cobas x 480, cobas HPV Test, 240/960 Tests (P100020/S032) | Roche Molecular Systems, Inc. | 2018-08-08 |
| Air Optix Aqua for Astigmatism / Aqua Multifocal / plus Hydraglyde / plus Hydraglyde Multifocal / plus Hydraglyde for As (P010019/S067) | Alcon Laboratories, Inc. | 2018-08-08 |
| Akreos Intraocular Lens (P060022/S024) | Bausch & Lomb, Inc. | 2018-08-07 |
| Carbomedics Prosthetic Heart Valve (CPHV) (P900060/S059) | Corcym S.r.l. | 2018-08-07 |
| comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S077) | CooperVision, Inc. | 2018-08-07 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S081) | Medtronic Cryocath, LP | 2018-08-07 |
| Aptima HCV Quant Dx Assay (P160023/S005) | Hologic, Inc. | 2018-08-07 |
| SUPARTZ FX and VISCO-3 (P980044/S048) | Seikagaku Corp. | 2018-08-07 |
| Gel-One (P080020/S030) | Seikagaku Corp. | 2018-08-07 |
| IDEAL IMPLANT Structured Breast Implant (P120011/S012) | Bimini Health Tech | 2018-08-06 |
| LIFEPAK 15 Monitor/Defibrillator (P160026/S001) | Physio-Control, Inc. | 2018-08-06 |
| HeartMate 3 Left Ventricular Assist System pump rotor sub-assembly (P160054/S004) | ABBOTT MEDICAL | 2018-08-06 |
| Preset Tips (P080004/S017) | Hoya Surgical Optics, Inc. | 2018-08-06 |
| LifeStent 5F Vascular Stent System (P070014/S057) | Bard Peripheral Vascular, Inc. | 2018-08-06 |
| HeartWare HVAD System (P100047/S124) | Medtronic | 2018-08-06 |
| enVista Hydrophobic Arcylic Intraocular Lens (P910056/S031) | Bausch & Lomb, Inc. | 2018-08-06 |
| MiniMed 530G System (P120010/S119) | Medtronic, Inc. | 2018-08-06 |
| MiniMed Paradigm Real-Time Revel System (P150019/S045) | Medtronic Minimed | 2018-08-06 |
| MiniMed 630G System with SmartGuard (P150001/S049) | Medtronic Minimed | 2018-08-06 |
| Guardian Connect System (P160007/S009) | Medtronic Minimed | 2018-08-06 |
| MiniMed iPro2 CGM System with Enlite Sensor (P150029/S021) | Medtronic Minimed | 2018-08-06 |
| MiniMed 670G System (P160017/S047) | Medtronic Minimed, Inc. | 2018-08-06 |
| Medtronic MiniMed 670G System / Giardian Senor (3) (P160017/S046) | Medtronic Minimed, Inc. | 2018-08-03 |
| Atellica IM Prostate-Specific Antigen (PSA) (P950021/S015) | Siemens Healthcare Diagnostics | 2018-08-03 |
| Zoll X Series Device (P160022/S005) | ZOLL Medical Corporation | 2018-08-03 |
| Atellica IM CPSA Assay (P990055/S016) | Siemens Healthcare Diagnostics | 2018-08-03 |
| Medtronic MiniMed 630G System with Guardian Sensor (3)/ Guardian Sensor (3) (P150001/S048) | Medtronic Minimed | 2018-08-03 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030/S091) | Zoll Manufacturing Corporation | 2018-08-03 |
| SofLEns 38 (polymacon) Visibility Tinted Contact Lens (N16895/S102) | Bausch & Lomb, Inc. | 2018-08-03 |
| Guardian Connect system / Guardian Sensor (3) (P160007/S008) | Medtronic Minimed | 2018-08-03 |
| GORE TIGRIS Vascular Stent (P160004/S017) | W. L. Gore & Associates, Inc. | 2018-08-03 |
| Revanesse Versa + (P160042/S003) | Prollenium Medical Technologies, Inc. | 2018-08-02 |
| Avalus Bioprosthesis (P170006/S006) | Medtronic, Inc. | 2018-08-02 |
| Restylane Injectable Gels (P040024/S102) | Q-Med AB | 2018-08-02 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Precision Spectra WaveWriter (P030017/S317) | Boston Scientific Corp | 2018-08-02 |
| NeuroPace RNS System (P100026/S056) | NeuroPace, Inc. | 2018-08-01 |
| NATRELLE Saline-Filled Breast Implants (P990074/S042) | Allergan | 2018-08-01 |
| ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses, Biomedics 55 Sphere, Biomedics Toric (P890023/S034) | The Cooper Companies | 2018-08-01 |
| Avitene Microfibrillar Collagen Hemostat (MCH) (N17600/S030) | Davol Inc., Sub. C. R. Bard, Inc. | 2018-08-01 |
| Precision Spectra, Spectra WaveWriter, Precision Montage, and Precision Montage MRI Spinal Cord Stimulatort (SCS) System (P030017/S316) | Boston Scientific Corp | 2018-08-01 |
| Obalon Balloon Kit (P160001/S018) | Medtimo, Inc. | 2018-08-01 |
| Absolute Pro Vascular Self-Expanding Stent System (P110028/S019) | Abbott Vascular, Inc. | 2018-08-01 |
| Blazer Open-Irrigated and IntellaNav Open-Irrgated Ablation Catheters (P150005/S035) | Boston Scientific Corp | 2018-08-01 |
| Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI an Spectra WaveWriter SPinal Cord Stimulator (P030017/S315) | Boston Scientific Corp | 2018-08-01 |
| Bard LifeStent 5F Vascular Stent System (P070014/S055) | Bard Peripheral Vascular, Inc. | 2018-08-01 |
| Avitene Microfibrillar Collagen Hemostat (MCH) (P800002/S023) | C.R. Bard, Inc. | 2018-08-01 |
| NATRELLE Silicone-Filled Breast Implants (P020056/S048) | Allergan | 2018-08-01 |
| Misago RX Self-expanding Peripheral Stent (P140002/S011) | Terumo Medical Corporation | 2018-08-01 |
| NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled (P040046/S029) | Allergan | 2018-08-01 |
| Esteem Totally Implantable Hearing Device (P090018/S037) | Envoy Medical Corporation | 2018-07-31 |
| Adherus AutoSpray Dural and ET Dural Sealant (P130014/S005) | Stryker Leibinger GmbH & Co KG | 2018-07-31 |
| SynchroMed Infusion System (P860004/S291) | Medtronic, Inc. | 2018-07-31 |
| TactiCath Quartz Contact Force Ablation Catheter (P130026/S035) | St Jude Medical | 2018-07-31 |
| AcrySof Posteriior Chamber Single Piece Intraocular Lenses (P930014/S112) | Alcon Laboratories, Inc. | 2018-07-31 |
| AcrySof IQ ReStor Posterior Chamber Intraocular Lenses (P040020/S079) | Alcon Research, Ltd. | 2018-07-31 |
| Celsius DS Electrophysiology Catheter (P010068/S057) | Biosense Webster, Inc. | 2018-07-30 |
| Implantable System for Remodulin (P140032/S015) | Medtronic, Inc. | 2018-07-30 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S313) | Medtronic, Inc. | 2018-07-30 |
| Smartablate Cable (P990071/S041) | Biosense Webster, Inc. | 2018-07-30 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S100) | Vistakon, Division of Johnson & Johnson Vision Car | 2018-07-30 |
| Celsius ThermoCool Electrophysiology Catheter, Navistar RMT Thermocool and Celsius RMT THermocool (P030031/S089) | Biosense Webster, Inc. | 2018-07-30 |
| Covera Vascular Covered Stent (P170042) | C.R. Bard, Inc. | 2018-07-30 |
| Navistar RMT Electrophysiology Catheter (P990025/S056) | Biosense Webster, Inc. | 2018-07-30 |
| Webster Electrophysiology Catheter, Celsius Electrophysiology Catheter, Electrophysiology Catheter Deflectable braided t (P950005/S070) | Biosense Webster, Inc. | 2018-07-30 |
| FINELINE II Sterox Lead, FINELINE II Sterox EZ Lead abnd Suture Sleeve Accessory (for FINELINE II Leads) (P960004/S085) | Boston Scientific | 2018-07-27 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S027) | Abbott Diabetes Care, Inc. | 2018-07-27 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S065) | W. L. Gore & Associates, Inc. | 2018-07-27 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S011) | W. L. Gore & Associates, Inc. | 2018-07-27 |