| Edwards Commander Delivery System (P140031/S076) | Edwards Lifesciences, LLC | 2018-10-25 |
| Elecsys total PSA (P990056/S034) | Roche Diagnostics Corp. | 2018-10-25 |
| Atellica IM Alpha Fetoprotein (AFP) (P930036/S009) | Siemens Healthcare Diagnostics, Inc. | 2018-10-25 |
| Atellica IM Complexed PSA (cPSA) (P990055/S017) | Siemens Healthcare Diagnostics | 2018-10-25 |
| AMS 700 Inflatable Penile Prosthesis (IPP) (with and without InhibiZone) (N970012/S146) | Boston Scientific Corp | 2018-10-25 |
| Obalon Balloon System (P160001/S008) | Medtimo, Inc. | 2018-10-25 |
| Zephyr Endobronchial Valve (EBV) System (P180002/S001) | Pulmonx Corporation | 2018-10-25 |
| Atellica IM Prostate-Specific Antigen (PSA) (P950021/S016) | Siemens Healthcare Diagnostics | 2018-10-25 |
| Elecsys free PSA Test System (P000027/S032) | Roche Diagnostics Corp. | 2018-10-25 |
| AspireAssist (P150024/S012) | Aspire Bariatrics, Inc. | 2018-10-24 |
| 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/S691) | Medtronic Cardiac Rhythm Disease Management | 2018-10-24 |
| Assurity MRI, Endurity MRI, Tendril MRI, MRI Activator, (P140033/S038) | ABBOTT MEDICAL | 2018-10-24 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S097) | Boston Scientific Corp | 2018-10-24 |
| EXCLUDER AAA Endoprosthesis (P020004/S159) | W. L. Gore & Associates, Inc. | 2018-10-24 |
| 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/S649) | Medtronic Cardiac Rhythm Disease Management | 2018-10-24 |
| AMS 700 Series Inflatable Penile Prosthesis (IPP) with and without InhibiZone, Ambicor IPP (N970012/S149) | Boston Scientific Corp | 2018-10-24 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S382) | Medtronic, Inc. | 2018-10-24 |
| Micra TPS (P150033/S044) | Medtronic, Inc. | 2018-10-24 |
| Durata, Optisure (P950022/S121) | ABBOTT MEDICAL | 2018-10-24 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Electrode (P110042/S114) | Boston Scientific Corporation | 2018-10-24 |
| Quartet, Victory, Zephyr, Accent, Assurity, Assurity+Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL D (P880086/S303) | ABBOTT MEDICAL | 2018-10-24 |
| Oxford Partial Knee System (P010014/S082) | Biomet Manufacturing Corp | 2018-10-24 |
| Allure, Allure Quadra, Quadra Allure MP (P030035/S174) | ABBOTT MEDICAL | 2018-10-24 |
| CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045/S032) | ABBOTT MEDICAL | 2018-10-24 |
| IsoFlex Optim (P960030/S060) | ABBOTT MEDICAL | 2018-10-24 |
| Tendril SDX Lead, Tendril ST Lead, OptiSense, Tendril STS Lead (P960013/S101) | ABBOTT MEDICAL | 2018-10-24 |
| Microny (P970013/S079) | ABBOTT MEDICAL | 2018-10-24 |
| ExAblate (Model 4000) System (P150038/S008) | Insightec | 2018-10-24 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S566) | Medtronic, Inc. | 2018-10-24 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex u, Quartet, Quartet CRT Leads (P030054/S360) | ABBOTT MEDICAL | 2018-10-24 |
| Fortify, Fortify Assura, Ellipse (P910023/S412) | ABBOTT MEDICAL | 2018-10-24 |
| LCS Total Knee System (P830055/S212) | Depuy, Inc. | 2018-10-23 |
| HeartWare Ventricular Assist System (P100047/S130) | Medtronic | 2018-10-23 |
| Belotero Balance Dermal Filler (P090016/S031) | Merz North America, Inc. | 2018-10-23 |
| Artisan Myopia (P030028/S006) | Ophtec BV | 2018-10-23 |
| KARL STORZ Photodynamic D-Light C (PDD) System (P050027/S013) | KARL STORZ Endoscopy-America, Inc. | 2018-10-23 |
| HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and Accessories (P160008/S002) | Heartsine Technologies, Ltd. | 2018-10-22 |
| Mosaic Bioprosthesis and Hancock II Bioprosthesis (P980043/S068) | Medtronic, Inc. | 2018-10-22 |
| IFORIA 5/7, ILESTO 57/, INVENTRA 7, IPERIA 5/7, ITREVIA 5/7, ILIVIA 5/7, INTICA 5/7, INLEXA 5/7, LUMAX 300/340 and 500/5 (P050023/S124) | Biotronik, Inc. | 2018-10-22 |
| Activa Deep Brain Stimulation Therapy System (P960009/S326) | Medtronic, Inc. | 2018-10-22 |
| LCS Total Knee System (P830055/S209) | Depuy, Inc. | 2018-10-22 |
| PSW 1802.U, ACTROS, AXOS, BA03, CYLOS, DROMOS, KAIROS, PHILOS, PHILOS II, PROTOS, EVIA, ENTOVIS, ECURO, EFFECTA, ESTELLA (P950037/S195) | Biotronik, Inc. | 2018-10-22 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S408) | Medtronic Neuromodulation | 2018-10-22 |
| STRATOS, EVIA, ENTOIVS, ELUNA 8, EPYRA 8, and ETRINSA 8 (P070008/S097) | Biotronik, Inc. | 2018-10-22 |
| BELOS, LEXOS, LUMOS, and XELOS (P000009/S077) | Biotronik, Inc. | 2018-10-22 |
| Mosaic Bioprosthesis and Hancock II Bioprosthesis (P990064/S076) | Medtronic, Inc. | 2018-10-22 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S018) | Nevro Corporation | 2018-10-21 |
| EnVeo R and EnVeo PRO delivery catheter system (DCS) (P130021/S054) | Medtronic, Inc. | 2018-10-21 |
| 9600CR Crimper (P140031/S075) | Edwards Lifesciences, LLC | 2018-10-19 |
| ARCHITECT Anti-HCV (P050042/S035) | Abbott Laboratories, Inc. | 2018-10-19 |
| Valiant Navion Thoracic Stent Graft System (P100040/S036) | Medtronic Vascular | 2018-10-19 |
| Model 203 Life Pulse High Frequency Ventilator (P850064/S037) | Bunnell, Inc. | 2018-10-19 |
| Optune System (P100034/S020) | Novocure, GmbH | 2018-10-19 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S039) | Boston Scientific Corporation | 2018-10-18 |
| Trident Alumina Insert (P000013/S015) | Howmedica Osteonics Corp. | 2018-10-18 |
| AMS Sphincter 800 Urinary Control System (P000053/S093) | Boston Scientific Corp | 2018-10-18 |
| Resolute Integrity Zotarolimus Eluting Coronary Stent System (P110013/S090) | Medtronic Vascular | 2018-10-18 |
| CapSure Epicardial Pacing Lead (P950024/S080) | Medtronic, Inc. | 2018-10-18 |
| 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, Mi (P980016/S688) | Medtronic Cardiac Rhythm Disease Management | 2018-10-18 |
| CapSure SP Novus Lead, CapSure Z Novus Lead, and Vitatron Impulse II Lead (P850089/S136) | Medtronic Cardiac Rhythm Disease Management | 2018-10-18 |
| CapSure VDD 2 Lead, Package Adaptor Cable and Vitatron Brilliant S+ VDD Lead (P890003/S397) | Medtronic, Inc. | 2018-10-18 |
| 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/S646) | Medtronic Cardiac Rhythm Disease Management | 2018-10-18 |
| Attesta MRI, Sphera MRI, Adapta, Versa, Sensia, Advisa, Advisa MRI, EnPulse and Kappa (P980035/S561) | Medtronic, Inc. | 2018-10-18 |
| Viva, Brava, Protecta, Protecta XT, COncerto, Concerto II, Consulta, Maximo II, InSync II Protect, Amplia, Compia and Cl (P010031/S644) | Medtronic Cardiac Rhythm Disease Management | 2018-10-18 |
| AED 3 BLS Device (P160022/S007) | ZOLL Medical Corporation | 2018-10-18 |
| Micra (P150033/S041) | Medtronic, Inc. | 2018-10-18 |
| Pulse Generator, Permanent Implantable (Device Reader/Interrogator) (P890003/S395) | Medtronic, Inc. | 2018-10-18 |
| SelectSecure Lead (P030036/S103) | Medtronic Cardiac Rhythm Disease Management | 2018-10-18 |
| Innova Vascular Self-Expanding Stent System (P140028/S033) | Boston Scientific Corporation | 2018-10-18 |
| Progensa PCA3 Assay (P100033/S009) | Gen-Probe Incorporated | 2018-10-18 |
| Epic Vascular Self-Expanding Stent System (P110035/S047) | Boston Scientific Corp | 2018-10-18 |
| CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead (P830061/S162) | Medtronic Cardiac Rhythm Disease Management | 2018-10-18 |
| Y Adaptor/Extender Kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint Quattro Lead, Subcutaneous Lead, and Tran (P920015/S218) | Medtronic, Inc. | 2018-10-18 |
| Revo MRI (P090013/S289) | Medtronic, Inc. | 2018-10-18 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, COnsulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena (P010015/S380) | Medtronic, Inc. | 2018-10-18 |
| Resolute Onyx Zotarolimus Eluting Coronary Stent System (P160043/S016) | Medtronic Vascular | 2018-10-18 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S101) | Abbott Vascular, Inc. | 2018-10-18 |
| Micra TPS (P150033/S042) | Medtronic, Inc. | 2018-10-18 |
| On-X Prosthetic Heart Valve, Model Onxa (P000037/S052) | On-X Life Technologies, Inc. | 2018-10-18 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S564) | Medtronic, Inc. | 2018-10-18 |
| Attain Ability Lead and Attain Performa Lead (P080006/S126) | Medtronic, Inc. | 2018-10-18 |
| Evera MRI, Evera, Marquis, Secura, Maximo II, Intrinsic, Protecta, Protecta XT, Virtuoso II, VIsia AF, Primo DR and VR M (P980016/S685) | Medtronic Cardiac Rhythm Disease Management | 2018-10-18 |
| HeartMate 3 Left Ventricular Assist System (P160054/S008) | ABBOTT MEDICAL | 2018-10-18 |
| CapSureFix MRI Lead (P090013/S290) | Medtronic, Inc. | 2018-10-18 |
| CapSureFix Lead, CapSureFix Novus Lead, and Vitatron Crystalline Active Fixation Lead (P930039/S191) | Medtronic, Inc. | 2018-10-18 |
| Consulta CRT-P, Syncra CRT-P and Viva CRT-P (P010015/S378) | Medtronic, Inc. | 2018-10-18 |
| Attain StarFix Lead (P060039/S090) | Medtronic, Inc. | 2018-10-18 |
| Myocardial Pacing Lead (P120017/S014) | Medtronic, Inc. | 2018-10-18 |
| Restylane Refyne, Restylane Defyne (P140029/S014) | Q-Med AB | 2018-10-17 |
| SURGICEL FIBRILLAR Absorbable Hemostats (N12159/S048) | ETHICON, Inc. | 2018-10-17 |
| PROGEL Pleural Air Leak Sealant (PALS) (P010047/S054) | Neomend, Inc. | 2018-10-17 |
| GORE Conformable TAG Thoracic Endoprosthesis (P040043/S105) | W. L. Gore & Associates, Inc. | 2018-10-17 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S027) | Ortho-Clinical Diagnostics | 2018-10-16 |
| BRACAnalysis CDx device (P140020/S015) | Myriad Genetic Laboratories | 2018-10-16 |
| Aptima HBV Quant Assay (P170025/S004) | Hologic, Inc. | 2018-10-16 |
| LINX Reflux Management System (P100049/S024) | Torax Medical | 2018-10-16 |
| Aptima HCV Quant Dx Assay (P160023/S004) | Hologic, Inc. | 2018-10-16 |
| BRACAnalysis CDx (P140020/S016) | Myriad Genetic Laboratories | 2018-10-16 |
| SCS Leads Specfiy Family (P840001/S409) | Medtronic Neuromodulation | 2018-10-16 |
| BIOFINITY (COMFILCON A) (P080011/S081) | CooperVision, Inc. | 2018-10-15 |