| CardioMEMS PA Sensor and Delivery Catheter (P100045/S020) | ABBOTT MEDICAL | 2017-06-15 |
| Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces Specify, and Vectris Spinal Cord Stimulation Lead (P840001/S363) | Medtronic Neuromodulation | 2017-06-15 |
| AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S062) | Boston Scientific Corp | 2017-06-15 |
| MARA Vapor System, MARA Vapor Probe Procedure Kit, MARA Vapor Generator and MARA Vapor Generator Accessory Kit (P160047) | CooperSurgical, Inc. | 2017-06-14 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S072) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-06-14 |
| Infuse Bone Graft (P050053/S039) | Medtronic, Inc. | 2017-06-14 |
| SYNERGY Everolimus Eluting Coronary Stent System (P150003/S031) | Boston Scientific Corporation | 2017-06-14 |
| Innova Vascular Self-Expanding Stent System (P140028/S026) | Boston Scientific Corporation | 2017-06-14 |
| RADIESSE INJECTABLE IMPLANT (P050052/S088) | Merz North America, Inc. | 2017-06-13 |
| Chilli II Cooled Ablation Catheter (P980003/S075) | Boston Scientific Corp | 2017-06-13 |
| Blazer Open-Irrigated Ablation Catheter, IntellaNav Open-Irrigated Ablation Catheter, Intella Tip MiFi Open-Irrigated Ab (P150005/S021) | Boston Scientific Corp | 2017-06-13 |
| RADIESSE 1.5CC AND 0.3CC (P050037/S076) | Merz North America, Inc. | 2017-06-13 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S331) | Medtronic, Inc. | 2017-06-13 |
| HeartWare Ventricular Assist System (P100047/S092) | Medtronic | 2017-06-13 |
| COAPTITE injectable implant (P040047/S044) | Merz North America, Inc. | 2017-06-13 |
| Nucleus AB1541 Auditory Brainstem Implant (P000015/S021) | Cochlear Americas | 2017-06-13 |
| Nucleus 24 Cochlear Implant System (P970051/S163) | Cochlear Americas | 2017-06-13 |
| NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM (P000015/S016) | Cochlear Americas | 2017-06-13 |
| ASTRA S DR MIR IPG, ASTRA S SR MRI IPG, ASTRA XT DR MRI, ASTRA XT SR MRI IPG (P980035/S505) | Medtronic, Inc. | 2017-06-13 |
| HeartWare Ventricular Assist System (P100047/S099) | Medtronic | 2017-06-13 |
| Nucleus Hybrid Cochlear Implant System (P130016/S027) | Cochlear Americas | 2017-06-13 |
| Durata / Optisure ( Passive); / Durata / Optisure (Active) (P950022/S106) | ABBOTT MEDICAL | 2017-06-13 |
| NUCLEUS HYBRID L24 IMPLANT SYSTEM (P130016/S022) | Cochlear Americas | 2017-06-13 |
| NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S151) | Cochlear Americas | 2017-06-13 |
| SynchroMed Infusion System (P860004/S279) | Medtronic, Inc. | 2017-06-12 |
| MYCARELINK PATIENT MONITOR MODEL (P890003/S368) | Medtronic, Inc. | 2017-06-09 |
| Biofinity Sphere and Biofinity XR Sphere ; Biofinity Toric and Biofinity XR Toric ; Biofinity Multifocal ; Biofinity Ene (P080011/S059) | CooperVision, Inc. | 2017-06-09 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S314) | Medtronic, Inc. | 2017-06-09 |
| Amplia, Brava, Claria , Compia, Converto, Maximo, Protecta, Viva (P010031/S572) | Medtronic Cardiac Rhythm Disease Management | 2017-06-09 |
| Animas, Vibe System (P130007/S026) | Animas Corp. | 2017-06-09 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S055) | Syncardia Systems, LLC | 2017-06-09 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis/ Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S162) | Edwards Lifesciences, LLC | 2017-06-09 |
| Esteem (P090018/S036) | Envoy Medical Corporation | 2017-06-09 |
| REVO MRI SURESCAN IPG (P090013/S242) | Medtronic, Inc. | 2017-06-09 |
| AMS 800 Urinary Control System (P000053/S079) | Boston Scientific Corp | 2017-06-09 |
| Evera MRI, Evera XT DR ICD, Intrinsic 30 ICD, Marquis VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Virtuoso II (P980016/S612) | Medtronic Cardiac Rhythm Disease Management | 2017-06-09 |
| Adapta, Versa, Sensia IPGEnPulse E1 IPG Kappa DR (Kappa 700/600) (P980035/S483) | Medtronic, Inc. | 2017-06-09 |
| Edwards Intuity Valve System (P150036/S011) | Edwards Lifesciences, LLC | 2017-06-09 |
| Inspire Medical System Model 3028 Hybrid Process (P130008/S026) | Inspire Medical Systems | 2017-06-09 |
| SCULPTRA AND SCULPTRA Aesthetic (P030050/S026) | Q-Med AB | 2017-06-09 |
| MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S012) | Medtronic, Inc. | 2017-06-09 |
| Micra TPS (P150033/S023) | Medtronic, Inc. | 2017-06-08 |
| Evera, Maximo, Protecta, Secura, Solara Quadripolar,Syncra, Viva MRI DF XT ICD CRT-P (P980016/S632) | Medtronic Cardiac Rhythm Disease Management | 2017-06-08 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P,Solar Bipolar CRT-P, (P010015/S329) | Medtronic, Inc. | 2017-06-08 |
| Consulta, Percepta, Serena, Solara Bipolar CRT-P, Quadripolar CRT-P (P010015/S330) | Medtronic, Inc. | 2017-06-08 |
| Amplia, Brava, Claria, Compia, Consulta, Maximo, Protecta XT MRI/CRT-D, Viva Quad S AF VR ICD (P010031/S593) | Medtronic Cardiac Rhythm Disease Management | 2017-06-08 |
| Myopore Sutureless Myocardial Pacing Lead (P130012/S003) | Great Batch Medical | 2017-06-08 |
| Adapta, Versa, Sensia IPG ADDR01, ADSR01, ADDR03, ADVDD01, ADDRS1, ADSR03, SEDR01, ADDR06, ADDRL1, ADSR06, SESR01, VEDR0 (P980035/S507) | Medtronic, Inc. | 2017-06-08 |
| TOTAL TEMPOROMANDIBULAR JOINT (TMJ) REPLACEMENT SYSTEM (P020016/S008) | Biomet Microfixation, Inc. | 2017-06-08 |
| EC-5000 EXCIMER LASER SYSTEM (P970053/S016) | Nidek Co., Ltd. | 2017-06-08 |
| Evera MRI DF-1 ICD DVMB1D1, DDMB1D1, DDMC3D1, DVMC3D1; Evera MRI ICD DDMC3D4, DVMB1D4, DVMC3D4, DDMB1D4; Evera S DR ICD (P980016/S633) | Medtronic Cardiac Rhythm Disease Management | 2017-06-08 |
| HeartWare Left Ventricular Assist System (P100047/S096) | Medtronic | 2017-06-08 |
| Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRTP W4TR01; Serena Bipolar CRT-P W1TR02, W4TR02; Solara Bipolar CRT (P010015/S332) | Medtronic, Inc. | 2017-06-08 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG (P980035/S501) | Medtronic, Inc. | 2017-06-08 |
| Amplia MRI CRTD DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4; DTBC1D1; Brava Quad CRTD (P010031/S594) | Medtronic Cardiac Rhythm Disease Management | 2017-06-08 |
| LCS(R) Total Knee System (P830055/S182) | Depuy, Inc. | 2017-06-08 |
| Revo MRI SureScan IPG RVDR01 (P090013/S257) | Medtronic, Inc. | 2017-06-08 |
| Adapta, Versa, Sensia IPG, Advisa DR/SR MRI IPG, ASTRA S DR MRI IPG, Relia IPG (P980035/S502) | Medtronic, Inc. | 2017-06-08 |
| AutoDELFIA hAFP Test System (P970037/S010) | Revvity, Inc. | 2017-06-07 |
| Superion Indirect Decompression System (P140004/S008) | Boston Scientific Neuromodulation | 2017-06-07 |
| NIRxcell CoCr Coronary Stent on RX (P110004/S022) | Medinol, Ltd. | 2017-06-07 |
| Model 3028 IPG (P130008/S025) | Inspire Medical Systems | 2017-06-07 |
| Inspire Medical Systems Model 3028 Implantable Pulse Generator (P130008/S024) | Inspire Medical Systems | 2017-06-07 |
| Edwards Crimper (P140031/S035) | Edwards Lifesciences, LLC | 2017-06-07 |
| QUANTTFERON-TB GOLD Plus (P010033/S031) | Qiagen | 2017-06-07 |
| Prometra Programmable Infusion Pump System (P080012/S043) | Infusyn Therapeutics, LLC | 2017-06-07 |
| Roche cobas HBV (P150014/S007) | Roche Molecular Systems, Inc. | 2017-06-07 |
| Roche cobas HCV (P150015/S006) | Roche Molecular Systems, Inc. | 2017-06-07 |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D) ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PUNCTUA, ENERGEN, INCEPTA, MOM (P010012/S449) | Boston Scientific Corp | 2017-06-06 |
| MiniMed 670G Insulin Pump (P160017/S013) | Medtronic Minimed, Inc. | 2017-06-06 |
| VNS THERAPY SYSTEM (P970003/S205) | LivaNova USA, Inc. | 2017-06-06 |
| Orbera Intragastric Balloon System (P140008/S006) | Boston Scientific Corporation | 2017-06-06 |
| Subcutaneous Implantable Defibrillator (S-ICD) EMBLEM MRI, S-ICD Gen 2. (P110042/S085) | Boston Scientific Corporation | 2017-06-06 |
| EXCOR Pediatric Ventricular Assist Device (P160035) | Berlin Heart, Inc. | 2017-06-06 |
| Ventana PD-L1 (SP142) Assay (P160002/S002) | Ventana Medical Systems, Inc. | 2017-06-06 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P,Solar Bipolar CRT-P, (P010015/S328) | Medtronic, Inc. | 2017-06-06 |
| DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING SYSTEM (P120005/S057) | Dexcom, Inc. | 2017-06-06 |
| Precision Novi Spinal Cord Stimulator (SCS) System (P030017/S287) | Boston Scientific Corp | 2017-06-06 |
| GORE, VIATORR TIPS Endoprosthesis - with Controlled Expansion (P040027/S056) | W. L. Gore & Associates, Inc. | 2017-06-06 |
| Edwards SAPIEN 3 Transcatheter Heart Vlave (P140031/S034) | Edwards Lifesciences, LLC | 2017-06-06 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG (P980035/S500) | Medtronic, Inc. | 2017-06-06 |
| Medtronic MiniMed 630G Insulin Pump (P150001/S015) | Medtronic Minimed | 2017-06-06 |
| Implantable Cardioverter Defibrillator (ICD) ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PUNCTUA, ENERGEN, INCEPTA, MOMENTUM, VIGI (P960040/S392) | Boston Scientific | 2017-06-06 |
| Sprint Quattro Lead (P920015/S197) | Medtronic, Inc. | 2017-06-05 |
| Edwards SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S028) | Edwards Lifesciences, LLC | 2017-06-05 |
| Lenstec Softec HD aspheric posterior chamber intraocular lens (P090022/S034) | Lenstec, Inc. | 2017-06-05 |
| Titan Device Tester (P980035/S504) | Medtronic, Inc. | 2017-06-05 |
| Sensar 1-Piece IOL, Tecnis 1-Piece IOL, Tecnis 1-Piece OptiBlue IOL, Preloaded Tecnis 1-Piece IOL, Preloaded Tecnis 1-Pi (P980040/S082) | Johnson & Johnson Surgical Vision, Inc. | 2017-06-05 |
| Adapta, Versa, Sensia IPG ADDRS1, ADSR01, ADDR03, SESR01, ADSR06, VEDR01, ADD01, SEDRL1, SED01, SES01, ADDR01, ADDRL1, A (P980035/S503) | Medtronic, Inc. | 2017-06-04 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG (P980035/S499) | Medtronic, Inc. | 2017-06-04 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P,Solar Bipolar CRT-P, (P010015/S327) | Medtronic, Inc. | 2017-06-04 |
| REFLECTION Ceramic Acetabular Hip System (RCHS) (P030022/S043) | Smith & Nephew, Inc. | 2017-06-02 |
| MOBI-C Cervical Disc Prosthesis (P110009/S019) | Highridge Medical, LLC | 2017-06-02 |
| R3 DELTA Ceramic Hip System (P150030/S002) | Smith & Nephew, Inc. | 2017-06-02 |
| SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P980040/S080) | Johnson & Johnson Surgical Vision, Inc. | 2017-06-02 |
| Adherus AutoSpray Dural Sealant (P130014/S004) | Stryker Leibinger GmbH & Co KG | 2017-06-02 |
| SpF Implantable Spinal Fusion Stimulators (P850035/S045) | Ahp Eos Buyer, Inc. | 2017-06-02 |
| FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM (P150021/S001) | Abbott Diabetes Care, Inc. | 2017-06-02 |
| MiniMed 630G System with SmartGuard (P150001/S008) | Medtronic Minimed | 2017-06-02 |
| EBI OsteoGen Implantable Bone Growth Stimulators (P790005/S056) | Ahp Eos Buyer, Inc. | 2017-06-02 |