| CapSure SP, Z Novus Lead; Vitatron Impulse II Lead (P850089/S138) | Medtronic Cardiac Rhythm Disease Management | 2018-11-19 |
| CapSureFix Lead, Novus Lead; Vitatron Crystalline Active Fixation Lead (P930039/S193) | Medtronic, Inc. | 2018-11-19 |
| Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR, VR ICD; Evera XT DR, VR ICD; Mirro MRI DR , VR ICD; Primo MRI DR, VR ICD; (P980016/S695) | Medtronic Cardiac Rhythm Disease Management | 2018-11-19 |
| LifePulse High Frequency Ventilator (P850064/S038) | Bunnell, Inc. | 2018-11-19 |
| Y Adaptor/Extender Kit; HV Splitter/Adaptor Kit; Sprint Quattro Lead. (P920015/S221) | Medtronic, Inc. | 2018-11-19 |
| Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve (P150048/S028) | Edwards Lifesciences, LLC | 2018-11-19 |
| Amplia MRI CRT-D, Quard CRT-D; Brava CRT-D, Quard CRT-D; Claria MRI CRT-D, Quard CRT-DCompia MRI CRT-D, Quard CRT-D; Con (P010031/S653) | Medtronic Cardiac Rhythm Disease Management | 2018-11-19 |
| Micra TPS (P150033/S046) | Medtronic, Inc. | 2018-11-19 |
| Myocardial Pacing Lead (P120017/S016) | Medtronic, Inc. | 2018-11-19 |
| RESTYLANE REFYNE and RESTYLANE DEFYNE (P140029/S015) | Q-Med AB | 2018-11-19 |
| Attain Ability Lead, Performa Lead (P080006/S128) | Medtronic, Inc. | 2018-11-19 |
| Inspire Model 4323 Sensing Lead (P130008/S036) | Inspire Medical Systems | 2018-11-19 |
| Epicardial Patch Lead (P900061/S151) | Medtronic Cardiac Rhythm Disease Management | 2018-11-19 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S184) | Edwards Lifesciences, LLC | 2018-11-19 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S094) | Edwards Lifesciences, LLC | 2018-11-19 |
| Attain StarFix Lead (P060039/S092) | Medtronic, Inc. | 2018-11-19 |
| EUFLEXXA (P010029/S027) | Ferring Pharmaceuticals, Inc. | 2018-11-19 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S077) | Edwards Lifesciences, LLC | 2018-11-19 |
| EDWARDS INTUITY Elite Valve System (P150036/S034) | Edwards Lifesciences, LLC | 2018-11-19 |
| Attain Bipolar OTW LV Lead; Consulta CRT-P; Percepta Bipolar CRT-P, Quadripolar CRT-P; Serena Bipolar CRT-P, Quardripola (P010015/S384) | Medtronic, Inc. | 2018-11-19 |
| CapSure Sense Lead, SP Novus Lead; Vitron Crystalline Lead (P830061/S164) | Medtronic Cardiac Rhythm Disease Management | 2018-11-19 |
| Adapta, Versa, Sensia IPG; Advisa DR, MRI IPG,SR MRI IPG, S DR, SR, XT DR, XT SR MRI IPG; Attesta DR, SR MRI IPG; Azure (P980035/S568) | Medtronic, Inc. | 2018-11-19 |
| CapSure Epicardial Pacing Lead (P950024/S082) | Medtronic, Inc. | 2018-11-19 |
| CapSureFix MRI Lead (P090013/S292) | Medtronic, Inc. | 2018-11-19 |
| CapSure VDD 2 Lead; Vitatron Brilliant S+ vdd Lead (P890003/S400) | Medtronic, Inc. | 2018-11-19 |
| AMS 700 Implantable Penile Prosthesis with and withoutInhibiZone (N970012/S152) | Boston Scientific Corp | 2018-11-16 |
| ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, RESONATE (P010012/S491) | Boston Scientific Corp | 2018-11-16 |
| PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, PERCIVA, RESONATE (P960040/S430) | Boston Scientific | 2018-11-16 |
| SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S108) | Spectranetics Corp. | 2018-11-16 |
| INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S066) | Boston Scientific | 2018-11-16 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ALTRUA, ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE (N970003/S232) | Boston Scientific Corp | 2018-11-16 |
| EMBLEM, EMBLEM MRI (P110042/S116) | Boston Scientific Corporation | 2018-11-16 |
| Spectranetics Laser Sheaths SLS (P960042/S065) | Spectranetics (Philips) | 2018-11-16 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S010) | Medinol, Ltd. | 2018-11-16 |
| INVIVE, INTUA, VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 (P030005/S178) | Guidant Corp. | 2018-11-16 |
| Superion® Indirect Decompression System (P140004/S010) | Boston Scientific Neuromodulation | 2018-11-16 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S031) | Medinol, Ltd. | 2018-11-16 |
| HEMOBLAST Bellows (P170012/S009) | Dilon Technologies, Inc. | 2018-11-16 |
| Oncomine Dx Target Test (P160045/S011) | Life Technologies Corporation | 2018-11-16 |
| MynxGrip and Mynx Ace Vascular Closure Device (P040044/S078) | Cordis US Corporation | 2018-11-16 |
| Biofinity Sphere (P080011/S083) | CooperVision, Inc. | 2018-11-16 |
| STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON (P160049/S003) | The Spectranetics Corp. | 2018-11-16 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S043) | Medtronic, Inc. | 2018-11-16 |
| Cervista HPV 16/18 Assay (P080015/S016) | Hologic, Inc. | 2018-11-15 |
| Evera MRI ICD,S DR ICD, S VR ICD, XT DR ICD, XT VR ICD; Mirro MRI DR ICD, VR ICD; Primo MRI DR ICD,VR ICD: Visia AF MRI (P980016/S694) | Medtronic Cardiac Rhythm Disease Management | 2018-11-15 |
| Cervista HPV HR Assay (P080014/S024) | Hologic, Inc. | 2018-11-15 |
| Amplia MRI CRT-D, Quad CRT-d; Brava CRT-D, Quad CRT-D; Claria MRI CRT-D, Quad CRT-D; Compia MRI CRT-D, Quad CRT-D; Viva (P010031/S652) | Medtronic Cardiac Rhythm Disease Management | 2018-11-15 |
| HeartWare Left Ventricular Assist System (P100047/S120) | Medtronic | 2018-11-15 |
| THERMOCOOL SMARTTOUCH SF Uni/Bi-Directional Navigation Catheter (P030031/S093) | Biosense Webster, Inc. | 2018-11-15 |
| ARCHITECT AUSAB (LN 1L82) (P050051/S034) | Abbott Laboratories, Inc. | 2018-11-14 |
| Guardian Connect System (P160007/S010) | Medtronic Minimed | 2018-11-14 |
| Paradigm Real-Time Revel System (P150019/S048) | Medtronic Minimed | 2018-11-14 |
| MiniMed 670G System (P160017/S052) | Medtronic Minimed, Inc. | 2018-11-14 |
| Minimed 530G System (P120010/S122) | Medtronic, Inc. | 2018-11-14 |
| iPro2 CGM System with Enlite Sensor (P150029/S022) | Medtronic Minimed | 2018-11-14 |
| St, Jude Medical Infinity Deep Brain Stimulation (DBS) Leads (P140009/S041) | ABBOTT MEDICAL | 2018-11-14 |
| Proclaim IPG (P010032/S144) | ABBOTT MEDICAL | 2018-11-14 |
| Trifecta Valve with Glide Technology (Trifecta GT) Trifecta Valve. (P100029/S037) | ABBOTT MEDICAL | 2018-11-14 |
| Minimed 630G System with Smartguard (P150001/S053) | Medtronic Minimed | 2018-11-14 |
| LCS(R) Total Knee System (P830055/S214) | Depuy, Inc. | 2018-11-14 |
| NuDel Delivery System (P150028/S002) | NuMED, Inc. | 2018-11-14 |
| Rayner C-Flex 570, C-Flex Aspheric 970C, 600C Aspheric Intraocular Lenses (P060011/S014) | Rayner Intraocular Lenses , Ltd. | 2018-11-14 |
| TECNIS Symfony Toric IOL (P980040/S093) | Johnson & Johnson Surgical Vision, Inc. | 2018-11-14 |
| Surpass Streamline Flow Diverter (P170024/S002) | Stryker Neurovascular | 2018-11-14 |
| ARCHITECT HBsAg Qualitative (LN 4P53) and HBsAg Qualitative Confirmatory (LN 4P54) (P110029/S028) | Abbott Laboratories | 2018-11-14 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S003) | Celonova Biosciences, Inc. | 2018-11-14 |
| CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead (P830061/S163) | Medtronic Cardiac Rhythm Disease Management | 2018-11-13 |
| ACE Header, End Cap, Epicardial Patch Lead and Upsizing Sleeve (P900061/S150) | Medtronic Cardiac Rhythm Disease Management | 2018-11-13 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S279) | Medtronic Neuromodulation | 2018-11-13 |
| CapSure Epicardial Pacing Lead (P950024/S081) | Medtronic, Inc. | 2018-11-13 |
| Transvene CS/SVC Lead (P980050/S120) | Medtronic, Inc. | 2018-11-13 |
| SURGICEL Powder (N12159/S049) | ETHICON, Inc. | 2018-11-13 |
| Myocardial Pacing Lead (P120017/S015) | Medtronic, Inc. | 2018-11-13 |
| CapSure SP Novus Lead, CapSure SP Z Lead and Vitatron Impulse II Lead (P850089/S137) | Medtronic Cardiac Rhythm Disease Management | 2018-11-13 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S318) | Medtronic, Inc. | 2018-11-13 |
| Edwards Commander Delivery System (P140031/S078) | Edwards Lifesciences, LLC | 2018-11-13 |
| SUPARTZ FX/VISCO-3 (P980044/S049) | Seikagaku Corp. | 2018-11-13 |
| Attain StarFix Lead (P060039/S091) | Medtronic, Inc. | 2018-11-13 |
| Attain Ability Lead and Attain Performa Lead (P080006/S127) | Medtronic, Inc. | 2018-11-13 |
| Itrel, Synergy and Intellis, Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spnal Cord Stimulation Lea (P840001/S411) | Medtronic Neuromodulation | 2018-11-13 |
| CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S192) | Medtronic, Inc. | 2018-11-13 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, COnsulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-D, Serena (P010015/S383) | Medtronic, Inc. | 2018-11-13 |
| CapSure VDD 2 Lead and Vitatron Brilliant S+ VDD Lead (P890003/S399) | Medtronic, Inc. | 2018-11-13 |
| Micra TPS (P150033/S045) | Medtronic, Inc. | 2018-11-13 |
| Anchoring Sleev Kit and SelectSecure LEad (P030036/S104) | Medtronic Cardiac Rhythm Disease Management | 2018-11-13 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead Ad (P920015/S220) | Medtronic, Inc. | 2018-11-13 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Mirro MRI DR ICD, Mirro VR ICD, Prim (P980016/S693) | Medtronic Cardiac Rhythm Disease Management | 2018-11-13 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI CRT-D, Claria MRI Q (P010031/S651) | Medtronic Cardiac Rhythm Disease Management | 2018-11-13 |
| Implantable System for Remodulin (P140032/S021) | Medtronic, Inc. | 2018-11-13 |
| ENDOTAK RELIANCE 4-SITE Leads (P910073/S151) | Boston Scientific | 2018-11-13 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S174) | Medtronic Neuromodulation | 2018-11-13 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S567) | Medtronic, Inc. | 2018-11-13 |
| CapSureFix MRI Lead (P090013/S291) | Medtronic, Inc. | 2018-11-13 |
| Activa Deep Brain Stimulation Therapy System (P960009/S328) | Medtronic, Inc. | 2018-11-13 |
| Adapta, Versa, Sensia IPG; Attesta SR MRI IPG; Relia IPG; Sphera SR MRI IPG (P980035/S569) | Medtronic, Inc. | 2018-11-12 |
| Thoratec HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S014) | ABBOTT MEDICAL | 2018-11-09 |
| Infuse Bone Graft (P050053/S042) | Medtronic, Inc. | 2018-11-09 |
| ARCHITECT Anti-HCV (LN 1L79) (P050042/S037) | Abbott Laboratories, Inc. | 2018-11-09 |
| INGEVITY Leads (P150012/S065) | Boston Scientific | 2018-11-09 |
| Infinity IPG (P140009/S042) | ABBOTT MEDICAL | 2018-11-09 |