| Pacemakers: ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 (N970003/S211) | Boston Scientific Corp | 2017-08-30 |
| Vistakon (Senofilcon A) Brand contact lenses (P040045/S080) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-08-30 |
| ICD; S-ICD, EMBLEM S-ICD MRI (P110042/S091) | Boston Scientific Corporation | 2017-08-30 |
| Innova Self-Expanding Stent System (P140028/S028) | Boston Scientific Corporation | 2017-08-29 |
| Percepta, Serena, Solara Bipolar/Quadripolar CRT-P (P010015/S338) | Medtronic, Inc. | 2017-08-29 |
| ASTRA XT DR/SR/MRI/IPG (P980035/S513) | Medtronic, Inc. | 2017-08-29 |
| DUROLANE (P170007) | Bioventus, LLC | 2017-08-29 |
| Radiesse (+) Lidocaine Injectable Implant (P050052/S097) | Merz North America, Inc. | 2017-08-29 |
| Seprafilm Adhesion Barrier (P950034/S048) | Baxter Healthcare Corporation | 2017-08-29 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S090) | Zoll Manufacturing Corporation | 2017-08-29 |
| Restylane-L, Restylane Lyft with Lidocaine, and Restylane Silk (P040024/S095) | Q-Med AB | 2017-08-28 |
| NATRELLE Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (P040046/S021) | Allergan | 2017-08-28 |
| NATRELLE Silicon-Filled Breast Implants (P020056/S040) | Allergan | 2017-08-28 |
| NATRELLE Saline-Filled Breast Implants (P990074/S037) | Allergan | 2017-08-28 |
| Voluma XC, Vollure XC, Volbella XC (P110033/S028) | Allergan | 2017-08-25 |
| LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010 (P170003) | Lutonix | 2017-08-25 |
| t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM (P140015/S020) | Tandem Diabetes Care, Inc. | 2017-08-25 |
| Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRT-P W4TR01; Serena Bipolar CRT-P W1TR02; Serena Quadripolar CRT-P (P010015/S341) | Medtronic, Inc. | 2017-08-25 |
| ASTRA S DR MRI IPG X3DR01; ASTRA S SR MRI IPG X3SR01; ASTRA XT DR MRI IPG X1DR01; ASTRA XT SR MRI IPG X1SR01 (P980035/S517) | Medtronic, Inc. | 2017-08-25 |
| Axium Neurostimulator System (P150004/S007) | ABBOTT MEDICAL | 2017-08-25 |
| ELCA Laser Catheters (P910001/S096) | Spectranetics Corp. | 2017-08-25 |
| PreveLeak Surgical Sealant (P100030/S007) | Baxter Healthcare Corporation | 2017-08-25 |
| Juvéderm Ultra, Ultra XC, Ultra, Juvéderm Ultra XC (P050047/S058) | Allergan | 2017-08-25 |
| Carpentier-Edwards PERIMOUNT Theon/RSR/Magna/Magna Ease Pericardial Aortic Bioprothesis / ThermaFix Tissue Process (P860057/S167) | Edwards Lifesciences, LLC | 2017-08-24 |
| SynchroMEd Infusion System (P860004/S287) | Medtronic, Inc. | 2017-08-24 |
| EDWARDS INTUITY ELITE Valve System (P150036/S016) | Edwards Lifesciences, LLC | 2017-08-24 |
| InterStim Therapy System, Verify Evaluation System (P970004/S251) | Medtronic Neuromodulation | 2017-08-24 |
| Cassette and Cassette Spacer (P150004/S013) | ABBOTT MEDICAL | 2017-08-24 |
| Activa Deep Brain Stimulation Therapy System (P960009/S288) | Medtronic, Inc. | 2017-08-24 |
| Restore, Itrel, Synergy and Intellis Sprinal Cord Stimulation Systems and Pisces, Specify,adn Vectris Sprinal Cord Stimu (P840001/S369) | Medtronic Neuromodulation | 2017-08-24 |
| InterStim Therapy System, Verify Evaluation System (P080025/S146) | Medtronic Neuromodulation | 2017-08-24 |
| Activa Deep Brain Stimulation Therapy System (P960009/S290) | Medtronic, Inc. | 2017-08-24 |
| HeartMate 3 Left Ventricular Assist System (P160054) | ABBOTT MEDICAL | 2017-08-23 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S386) | ABBOTT MEDICAL | 2017-08-23 |
| Nucleus Auditory Brainstem Implant (P000015/S024) | Cochlear Americas | 2017-08-23 |
| Promote+ / Unify Quadra /Unity Assura/ Quadra Assura / Quadra Assura MP (P030054/S335) | ABBOTT MEDICAL | 2017-08-23 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S283) | ABBOTT MEDICAL | 2017-08-23 |
| SmartAblate System Foot Pedal. (P990071/S036) | Biosense Webster, Inc. | 2017-08-23 |
| Microny family of Pacemakers (P970013/S071) | ABBOTT MEDICAL | 2017-08-23 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S008) | ABBOTT MEDICAL | 2017-08-23 |
| Current+ / Fortify / Fortify Assura / Ellipse. (P910023/S391) | ABBOTT MEDICAL | 2017-08-23 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S157) | ABBOTT MEDICAL | 2017-08-23 |
| Nucleus 24 Cochlear Implant System (P970051/S168) | Cochlear Americas | 2017-08-23 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/ II HF/ II (P030054/S329) | ABBOTT MEDICAL | 2017-08-23 |
| VenaSeal Closure System (P140018/S006) | Medtronic Vascular, Inc. | 2017-08-22 |
| Endurant, Endurant II and Endurant IIs Stent Graft System (P100021/S067) | Medtronic Vascular | 2017-08-22 |
| Impella 2.5, Impella CP Systems (P140003/S017) | Abiomed, Inc. | 2017-08-22 |
| Assurity, Assurity+, Endurity families of ICD Devices (P880086/S284) | ABBOTT MEDICAL | 2017-08-22 |
| ELCA Catheters (P910001/S095) | Spectranetics Corp. | 2017-08-22 |
| Open Pivot Heart Valve, Open Pivot Aortic Valved Graft (P990046/S049) | Medtronic Ats Medical, Inc. | 2017-08-22 |
| Visual Integrity Inspection (P100010/S067) | Medtronic Cryocath, LP | 2017-08-22 |
| IntellaNav MiFi Open-Irrigated Ablation Catheter (P150005/S017) | Boston Scientific Corp | 2017-08-22 |
| BioGlue Surgical Adhesive (P010003/S027) | Cryolife, Inc. | 2017-08-21 |
| NATRELLE Silicone-Filled Breast Implants (P020056/S044) | Allergan | 2017-08-21 |
| Edwards Pericardial Aortic Bioprosthesis (P150048/S002) | Edwards Lifesciences, LLC | 2017-08-21 |
| NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (P040046/S025) | Allergan | 2017-08-21 |
| Orbera Intragastric Balloon (P140008/S007) | Boston Scientific Corporation | 2017-08-21 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S011) | Abbott Diabetes Care, Inc. | 2017-08-21 |
| Impella Ventricular Support Systems (P140003/S024) | Abiomed, Inc. | 2017-08-21 |
| Prometra Programmable Infusion Pump System (P080012/S045) | Infusyn Therapeutics, LLC | 2017-08-21 |
| NATRELLE Saline-Filled Breast Implants (P990074/S040) | Allergan | 2017-08-21 |
| PreveLeak Surgical Sealant / PreveLeak Surgical Sealant 10pk applicator tips (P100030/S010) | Baxter Healthcare Corporation | 2017-08-21 |
| MONOVISC High Molecular Weight Hyaluronan (P090031/S008) | Anika Therapeutics, Inc. | 2017-08-21 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S146) | W. L. Gore & Associates, Inc. | 2017-08-18 |
| CERAMAX Ceramic Total Hip System (P070026/S040) | DePuy Orthopaedics, Inc. | 2017-08-18 |
| CyPass Micro-Stent (P150037/S006) | Alcon Research, Ltd. | 2017-08-18 |
| Therakos CELLEX Procedural Kit (P860003/S094) | Therakos Development Limited | 2017-08-18 |
| Micra Transcatheter Pacing System (P150033/S026) | Medtronic, Inc. | 2017-08-18 |
| GORE TAG Thoracic Endoprosthesis (P040043/S094) | W. L. Gore & Associates, Inc. | 2017-08-18 |
| Voltage Ceramic Capacitors (P110042/S090) | Boston Scientific Corporation | 2017-08-18 |
| Flextome Cutting Balloon Microsurgical Dilatation Device/Wolverine Coronary Cutting Balloon Monorail (MR) / Wolverine Co (P950020/S081) | Boston Scientific Corp | 2017-08-18 |
| SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S007) | Globus Medical, Inc. | 2017-08-18 |
| Percepta Bipolar CRT-P/ Percepta Quadripolar CRT-P/ Serena Bipolar CRT-P/ Serena Quadripolar CRT-P/ Solar Bipolar CRT-P/ (P010015/S339) | Medtronic, Inc. | 2017-08-17 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S104) | Boston Scientific | 2017-08-17 |
| Animas Vibe System (P130007/S029) | Animas Corp. | 2017-08-17 |
| PROMUS Element Plus Everolimus-Eluting Stent System/ PROMUS PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent (P110010/S143) | Boston Scientific Corp | 2017-08-17 |
| Thoratec, HeartMate II, Ventricular Assist System (P060040/S067) | ABBOTT MEDICAL | 2017-08-17 |
| Rotablator Rotational Atherectomy System (P900056/S163) | Boston Scientific Corp | 2017-08-17 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S023) | Boston Scientific Corp | 2017-08-17 |
| DuraSeal TM Dural Sealant System (P040034/S026) | Integra LifeSciences Corporation | 2017-08-17 |
| REBEL Platinum CHromum Coronary Stent System (P130030/S042) | Boston Scientific Corp | 2017-08-17 |
| Express SD Monorail Premounted Stent System (P060006/S084) | Boston Scientific Corp | 2017-08-17 |
| IN.PACT Admiral Paclitaxel-Coated Balloon Catheter (P140010/S036) | Medtronic, Inc. | 2017-08-17 |
| RCHS Ceramic Liners and Shells (P030022/S044) | Smith & Nephew, Inc. | 2017-08-17 |
| HeartWare Left Ventricular Assist Device System (P100047/S103) | Medtronic | 2017-08-17 |
| THERAKOS CELLEX Photopheresis Procedural Kit (P860003/S092) | Therakos Development Limited | 2017-08-17 |
| Chilli II Coole dAblation Catheter and Cable (P980003/S077) | Boston Scientific Corp | 2017-08-17 |
| ASTRA S DR MRI IPG/ ASTRA S SR MRI IPG / ASTRA XT DR MRI IPG / ASTRA XT SR MRI IPG (P980035/S515) | Medtronic, Inc. | 2017-08-17 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S100) | Boston Scientific Corp | 2017-08-17 |
| Endurant Stent Graft System (P100021/S066) | Medtronic Vascular | 2017-08-17 |
| SynchroMed Infusion System (P860004/S283) | Medtronic, Inc. | 2017-08-16 |
| Blind plug BS IS4 (P050023/S111) | Biotronik, Inc. | 2017-08-16 |
| CapSure Sense Lead/CapSure SP Novus Lead/CapSureSense Lead/Vitatron Crystalline Lead (P830061/S149) | Medtronic Cardiac Rhythm Disease Management | 2017-08-16 |
| Setrox S53, S60, Safio S 53, S 60, Solia S 45, S 53, S 60, Siello S 45, S 53, s 60, Blind plug BS IS-1 (P950037/S177) | Biotronik, Inc. | 2017-08-16 |
| Attain StarFix Lead (P060039/S081) | Medtronic, Inc. | 2017-08-16 |
| MINIMED 630G SYSTEM WITH SMARTGUARD ENLITE SENSOR (P150001/S019) | Medtronic Minimed | 2017-08-16 |
| InterStim Therapy System (SNS Bowel Programming Systems) (P080025/S143) | Medtronic Neuromodulation | 2017-08-16 |
| Elecsys Anti-HBc Immunoassay test system (P100031/S017) | Roche Diagnostics Corp. | 2017-08-16 |
| CapSureFix Novus MRI SureScan Lead (P930039/S170) | Medtronic, Inc. | 2017-08-16 |
| Nucleus 24 Cochlear Implant System (P970051/S167) | Cochlear Americas | 2017-08-16 |