| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) (P070008/S100) | Biotronik, Inc. | 2019-02-25 |
| Defibrillator, Implantable Cardioverter, with Cardiac Resynchronization (Crt-D); Defibrillator, Implantable, Dual-Chambe (P050023/S129) | Biotronik, Inc. | 2019-02-25 |
| Progel Pleural Air Leak Sealant (P010047/S061) | Neomend, Inc. | 2019-02-22 |
| LATITUDE NXT Patient Management System, LATITUDE Wave Communicator, LATITUDE Consult Communicator and LATITUDE NXT Syste (P910077/S168) | Boston Scientific | 2019-02-22 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S013) | Medinol, Ltd. | 2019-02-22 |
| MED-EL Cochlear Implant System (P000025/S107) | Med-El Corp. | 2019-02-22 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 supported by LATITUDE Consult (N970003/S233) | Boston Scientific Corp | 2019-02-22 |
| Tridyne Vascular Sealant (P150016/S017) | Neomend, Inc. | 2019-02-22 |
| INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI (Pacemaker Devices) (P150012/S067) | Boston Scientific | 2019-02-22 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, and PERCIVA (ICD Dev (P960040/S431) | Boston Scientific | 2019-02-22 |
| EMBLEM (Subcutaneous ICD Devices) (P110042/S119) | Boston Scientific Corporation | 2019-02-22 |
| INVIVE, INTUA, VISIONIST and VALITUDE (CRT-P Resynchronization Devices) (P030005/S179) | Guidant Corp. | 2019-02-22 |
| ORSIRO Sirolimus Eluting Coronary Stent System (P170030) | Biotronik AG | 2019-02-22 |
| Absorbable Collagen Plug for Dental Surgery, Absorbable Collagen Tape for Dental Surgery (P840062/S068) | Integra Lifesciences Corp. | 2019-02-22 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM and VIGILIANT (CRT-D Resynchroni (P010012/S492) | Boston Scientific Corp | 2019-02-22 |
| HeartWare Ventricular Assist System (P100047/S133) | Medtronic | 2019-02-21 |
| Biofinity toric (P080011/S089) | CooperVision, Inc. | 2019-02-21 |
| Endurant, Endurant II, Endurant IIs Stent Graft Systems (P100021/S075) | Medtronic Vascular | 2019-02-21 |
| KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM (P050027/S014) | KARL STORZ Endoscopy-America, Inc. | 2019-02-21 |
| MiniMed 670G System (P160017/S054) | Medtronic Minimed, Inc. | 2019-02-21 |
| Myopore Sutureless Myocardial Pacing Lead (P130012/S006) | Great Batch Medical | 2019-02-21 |
| MiniMed 630G System (P150001/S058) | Medtronic Minimed | 2019-02-21 |
| Plexa ProMRI S DX ICD Leads (P980023/S089) | Biotronik, Inc. | 2019-02-21 |
| Perclose ProGlide Suture-Mediated Closure System/Prostar XL Percutaneous Vascular Surgical System (P960043/S102) | Abbott Vascular, Inc. | 2019-02-21 |
| StarClose SE Vascular Surgical System (P050007/S037) | Abbott Vascular Devices | 2019-02-21 |
| Cologuard (P130017/S025) | Exact Sciences Corporation | 2019-02-20 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S007) | Celonova Biosciences, Inc. | 2019-02-20 |
| XACT Carotid Stent System (P040038/S034) | Abbott Vascular, Inc. | 2019-02-20 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S026) | Boston Scientific Corp | 2019-02-20 |
| MULTI-LINK 8, MULTI-LINK 8 SV, and MULTI-LINK 8 LL Coronary Stent System (P020047/S071) | Abbott Vascular | 2019-02-20 |
| XIENCE PRIME, SV, LL; XIENCE Xpedition, SV, LL; Everolimus Eluting Coronary Stent Systems;XIENCE Alpin and Sierra Everol (P110019/S104) | Abbott Vascular | 2019-02-20 |
| Supera Peripheral Stent System (P120020/S021) | Abbott Vascular (Idef Technologies Inc) | 2019-02-20 |
| XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent Systems (P070015/S144) | Abbott Vascular, Inc. | 2019-02-20 |
| SynCardia temporary Total Artifical Heart (TAH-t) System (P030011/S067) | Syncardia Systems, LLC | 2019-02-20 |
| SURGIFLO Hemostatic Matrix Kit w/Thrombin (P990004/S033) | Ferrosan Meidcal Devices A/S | 2019-02-20 |
| Accolade MRI Pacemakers (P150012/S071) | Boston Scientific | 2019-02-19 |
| LIFEPAK® CR2 Defibrillator (P170018/S002) | Physio-Control, Inc. | 2019-02-19 |
| WOLVERINE Coronary Cutting Balloon (P950020/S093) | Boston Scientific Corp | 2019-02-19 |
| HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and Accessories (P160008/S004) | Heartsine Technologies, Ltd. | 2019-02-19 |
| Avalus Bioprosthesis (P170006/S009) | Medtronic, Inc. | 2019-02-19 |
| Accolade Pacemakers (N970003/S235) | Boston Scientific Corp | 2019-02-19 |
| R3 delta Ceramic Acetabular System (P150030/S006) | Smith & Nephew, Inc. | 2019-02-19 |
| Accolade Cardiac Resynchronization Therapy Pacemakers (P030005/S181) | Guidant Corp. | 2019-02-19 |
| LIFEPAK CR2 Defibrillator (P170018/S001) | Physio-Control, Inc. | 2019-02-19 |
| Certitude Introducer sheath set and Crimper (P140031/S081) | Edwards Lifesciences, LLC | 2019-02-18 |
| MAS 700 Inflatable Penile PRosthesis (IP) with and without InhibiZone (N970012/S155) | Boston Scientific Corp | 2019-02-15 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S012) | Medinol, Ltd. | 2019-02-15 |
| Maestro Rechargeable System (P130019/S019) | Reshape Lifesciences, Inc. | 2019-02-15 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S039) | St Jude Medical | 2019-02-15 |
| Implantable System for Remodulin (P140032/S020) | Medtronic, Inc. | 2019-02-15 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S156) | Boston Scientific Corp | 2019-02-15 |
| PROMUS Element Plus Everolimus Eluting Platinum Chromium Coronary Stent System Monorail (MR) and Over-THe-Wire (OTW); Pr (P110010/S162) | Boston Scientific Corp | 2019-02-14 |
| 4CH & 8CH Infinity DBS System FLex Extension (P140009/S038) | ABBOTT MEDICAL | 2019-02-14 |
| WOLVERINE Coronary Cutting Balloon (P950020/S094) | Boston Scientific Corp | 2019-02-14 |
| SYNERGY Everolimus Eluting Platinum Chromium Coronary Stent System Monorail (MR) and Over-The-Wire (OTW) (P150003/S046) | Boston Scientific Corporation | 2019-02-14 |
| Obalon Balloon System (P160001/S030) | Medtimo, Inc. | 2019-02-14 |
| LifeVest Wearable Defibrillator (P010030/S113) | Zoll Manufacturing Corporation | 2019-02-14 |
| VNS Therapy System (P970003/S222) | LivaNova USA, Inc. | 2019-02-14 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (P130024/S026) | Lutonix | 2019-02-14 |
| REBEL Stent System Monorail (MR) and Over-The-Wire (OTW) (P130030/S059) | Boston Scientific Corp | 2019-02-14 |
| Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P (P010015/S390) | Medtronic, Inc. | 2019-02-13 |
| Oncomine Dx Target Test (P160045/S013) | Life Technologies Corporation | 2019-02-13 |
| Micra TPS (P150033/S048) | Medtronic, Inc. | 2019-02-13 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S065) | W. L. Gore & Associates, Inc. | 2019-02-13 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S011) | Medinol, Ltd. | 2019-02-13 |
| NG4 Devices (P010012/S497) | Boston Scientific Corp | 2019-02-13 |
| 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/S575) | Medtronic, Inc. | 2019-02-13 |
| GORE VIABAHN Endoprosthesis (P040037/S126) | W. L. Gore & Associates, Inc. | 2019-02-13 |
| NG3 Devices (P960040/S433) | Boston Scientific | 2019-02-13 |
| Wolverine Coronary Cutting Balloon (P950020/S095) | Boston Scientific Corp | 2019-02-12 |
| Evia DR/SR; Evia DR-T/SR-T; Entovis DR/SR, Entovis DR-T/SR-T; Estella DR/SR; Estella DR-T/SR-T; Effecta D/S; Edora 8 DR/ (P950037/S192) | Biotronik, Inc. | 2019-02-12 |
| SynchroMed Infusion System (P860004/S321) | Medtronic, Inc. | 2019-02-12 |
| Evia HF/ HF-T; Entovis HF/ HF-T; Edora 8 HF-T; Enitra 8 HF-T; Enticos 8 HF-T; Evity 8 HF-T; Etrinsa 8 HF T; Epyra 8 HF-T (P070008/S094) | Biotronik, Inc. | 2019-02-12 |
| EFH-16; S 60-K; S 60-J; S 60-S (P820076/S027) | Biotronik, Inc. | 2019-02-12 |
| Ilesto 7 VR-T; Iforia 7 VR-T; Ilesto 5 VR-T; Iforia 5 VR-T; Ilesto 7 VR T DX; Iforia 7 VR-T DX; Ilesto 5 VR-T DX; Iforia (P050023/S121) | Biotronik, Inc. | 2019-02-12 |
| Protego SD/TD; Protego DF-1 SD; Protego ProMRI SDX; Protego DF-1 ProMRI SD; Plexa SD; Plexa ProMRI SD; Plexa DF-1 SD; Pl (P980023/S085) | Biotronik, Inc. | 2019-02-12 |
| Activa Deep Brain Stimulation Therapy System (P960009/S332) | Medtronic, Inc. | 2019-02-12 |
| Attain Ability Lead (P080006/S130) | Medtronic, Inc. | 2019-02-11 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S038) | St Jude Medical | 2019-02-11 |
| Perceval Heart Valve (P150011/S015) | Corcym S.r.l. | 2019-02-08 |
| BARRICAID ANULAR CLOSURE DEVICE (ACD) (P160050) | Intrinsic Therapeutics | 2019-02-08 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S019) | Nevro Corporation | 2019-02-08 |
| ASPIRE Cristalle Breast Tomosynthesis System (P160031/S001) | Fujifilm Medical Systems U.S.A, Inc. | 2019-02-08 |
| M6-C Artificial Cervical Disc (P170036) | Spinal Kinetics, LLC | 2019-02-06 |
| Cardiva VASCADE Vascular Closure System (VCS) (P120016/S026) | Cardiva Medical, Inc. | 2019-02-05 |
| LCS(R) Total Knee System (P830055/S221) | Depuy, Inc. | 2019-02-04 |
| ACUITY X4 E24 Molding NOR Optimization (P010012/S496) | Boston Scientific Corp | 2019-02-04 |
| Implantable System for Remodulin (P140032/S026) | Medtronic, Inc. | 2019-02-04 |
| MANTA Vascular Closure Device (P180025) | Teleflex Medical, LLC | 2019-02-01 |
| VNS Therapy System (P970003/S219) | LivaNova USA, Inc. | 2019-02-01 |
| Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor , Eversense Insertion Tools, Evers (P160048/S003) | Senseonics, Incorporated | 2019-02-01 |
| Juvederm injectable Gel Implants (P050047/S067) | Allergan | 2019-01-31 |
| Juvederm Injectable Gel Implants (P110033/S041) | Allergan | 2019-01-31 |
| LCS(R) TruMatch Peronalized Solutions (P830055/S217) | Depuy, Inc. | 2019-01-31 |
| Prometra Programmable Infusion Pump System (P080012/S050) | Infusyn Therapeutics, LLC | 2019-01-31 |
| Sangia Total PSA Test (P170037) | Opko Diagnostics, LLC | 2019-01-30 |
| remede® System (P160039/S004) | Respicardia | 2019-01-30 |
| iDESIGN Refractive Studio; STAR Excimer Laser System (P930016/S055) | Amo Manufacturing USA, LLC | 2019-01-29 |
| Prometra Programmable Infusion Pump System (P080012/S040) | Infusyn Therapeutics, LLC | 2019-01-28 |
| comfilcon A (P080011/S088) | CooperVision, Inc. | 2019-01-28 |