| GORE VIABAHN ENDOPROSTHESIS (P040037/S065) | W. L. Gore & Associates, Inc. | 2014-06-20 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S096) | W. L. Gore & Associates, Inc. | 2014-06-20 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S443) | Medtronic Cardiac Rhythm Disease Management | 2014-06-20 |
| LATITUDE NXT 2.0 PATIENT MANAGEMENT SYSTEM (P910077/S140) | Boston Scientific | 2014-06-20 |
| PROTECTA ICD & PROTECTA XT ICD (P980016/S481) | Medtronic Cardiac Rhythm Disease Management | 2014-06-20 |
| STRATOS, EVIA, & ENTOVIS FAMILIES OF CRT-P'S (P070008/S049) | Biotronik, Inc. | 2014-06-20 |
| SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) (P030011/S025) | Syncardia Systems, LLC | 2014-06-20 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S092) | W. L. Gore & Associates, Inc. | 2014-06-20 |
| PROTECTA CRT-D & PROTECTA XT CRT-D (P010031/S443) | Medtronic Cardiac Rhythm Disease Management | 2014-06-20 |
| GORE VIABAHN ENDOPROSTHESIS (P130006/S005) | W. L. Gore & Associates, Inc. | 2014-06-20 |
| CYLOS, PHILOS/PHILOS II, EVIA, ENTOVIA, ECURO, EFFECTA, & ESTELLA FAMILIES OF PACEMAKERS (P950037/S131) | Biotronik, Inc. | 2014-06-20 |
| GORE TAG THORACIC ENDOPROSTHESIS (P040043/S062) | W. L. Gore & Associates, Inc. | 2014-06-20 |
| ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD (P910023/S331) | ABBOTT MEDICAL | 2014-06-20 |
| VERIFY EVALUATION SYSTEM FOR INTERSTIM THERAPY FOR BOWEL CONTROL; VERIFY CONTROLLER (P080025/S070) | Medtronic Neuromodulation | 2014-06-19 |
| RADIESSE (P050052/S054) | Merz North America, Inc. | 2014-06-19 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S057) | Hologic, Inc. | 2014-06-19 |
| RADIESSE (P050037/S049) | Merz North America, Inc. | 2014-06-19 |
| VERIFY EVALUATION SYSTEM;FOR INTERSTIM THERAPY FOR URINARY CONTROL (P970004/S174) | Medtronic Neuromodulation | 2014-06-19 |
| COAPTITE INJECTABLE IMPLANT (P040047/S035) | Merz North America, Inc. | 2014-06-19 |
| NEUROPACE RNS SYSTEM (P100026/S018) | NeuroPace, Inc. | 2014-06-18 |
| GLUCOSE SENSOR ENLITE (P120010/S019) | Medtronic, Inc. | 2014-06-18 |
| GORE VIABAHN ENDOPROSTHESIS (P040037/S064) | W. L. Gore & Associates, Inc. | 2014-06-18 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S020) | Dexcom, Inc. | 2014-06-18 |
| EVERA S DR ICD , EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S485) | Medtronic Cardiac Rhythm Disease Management | 2014-06-18 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S095) | W. L. Gore & Associates, Inc. | 2014-06-18 |
| EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM (P050039/S016) | Exactech, Inc. | 2014-06-18 |
| AFX ENDOVASCULAR AAA SYSTEM (P040002/S046) | Endologix, LLC | 2014-06-18 |
| FORTIFY AND FORTIFY ASSURA ICDS (P910023/S338) | ABBOTT MEDICAL | 2014-06-18 |
| MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY. (MYNX PRODUCT FAMILY) (P040044/S054) | Cordis US Corporation | 2014-06-18 |
| ARCHITECT TOTAL PSA (LN 6C06) (P910007/S045) | Abbott Laboratories | 2014-06-18 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S447) | Medtronic Cardiac Rhythm Disease Management | 2014-06-18 |
| ARCHITECT FREE PSA (LN 6C07) (P980007/S036) | Abbott Laboratories | 2014-06-18 |
| UNIFY, UNIFY ASSURA, UNIFY QUADRA, AND QUADRA ASSURA CRT-DS (P030054/S270) | ABBOTT MEDICAL | 2014-06-18 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS,CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL AORTIC BIOP (P860057/S125) | Edwards Lifesciences, LLC | 2014-06-18 |
| GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S004) | W. L. Gore & Associates, Inc. | 2014-06-18 |
| ALAIR BRONCHIAL THERMOPLASTY RADIOFREQUENCY CONTROLLER (P080032/S015) | Boston Scientific Corp | 2014-06-17 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S026) | Smith & Nephew, Inc. | 2014-06-17 |
| FLUENCY PLUS ENDOVASCULAR STENT GRAFT (P130029) | Bard Peripheral Vascular, Inc. | 2014-06-17 |
| CAPSUREFIX LEAD (P930039/S109) | Medtronic, Inc. | 2014-06-17 |
| REVO MRI IPG (P090013/S143) | Medtronic, Inc. | 2014-06-17 |
| ADAPTA, VERSA, SENSIA IPG, ADVISA DRIPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S378) | Medtronic, Inc. | 2014-06-17 |
| BARD LIFESTENT VASCULAR STENT (P070014/S046) | Bard Peripheral Vascular, Inc. | 2014-06-17 |
| PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM (P030017/S191) | Boston Scientific Corp | 2014-06-17 |
| DYNAGEN, INOGEN, ORIGEN (P010012/S357) | Boston Scientific Corp | 2014-06-17 |
| BRAVA CRT-D, CONCETO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA S CRT-D, XT CRT-D (P010031/S446) | Medtronic Cardiac Rhythm Disease Management | 2014-06-17 |
| NUCLEUS 24 COCHLEAR IMPLANT (P970051/S120) | Cochlear Americas | 2014-06-17 |
| EVERA S DR ICD, VR ICD, XT DR ICDXT VR ICD, MAXIMO II ICD PROTECTA ICD, XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S484) | Medtronic Cardiac Rhythm Disease Management | 2014-06-17 |
| NUCLEUS 24 HYBRID SYSTEM (P130016/S006) | Cochlear Americas | 2014-06-17 |
| DYNAGEN, INOGEN, ORIGEN (P960040/S318) | Boston Scientific | 2014-06-17 |
| SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S001) | Scott Laboratories, Inc. | 2014-06-16 |
| SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) (P090022/S020) | Lenstec, Inc. | 2014-06-16 |
| EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009) | Edwards Lifesciences, LLC | 2014-06-16 |
| ISERT GEMETRIC MODEL 750 AND ISERT GEMETRIC MODEL 751 INTRAOCULAR LENS (IOL) (P080004/S015) | Hoya Surgical Optics, Inc. | 2014-06-16 |
| SOFTEE HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) (P090022/S022) | Lenstec, Inc. | 2014-06-16 |
| AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S050) | Boston Scientific Corp | 2014-06-16 |
| EXABLATE SYSTEM (P040003/S014) | Insightec, Ltd. | 2014-06-13 |
| PATHWAY ANTI-C-KIT (9.7) RABBITT MONOCLONAL PRIMARY ANTOBODY (P020055/S010) | Ventana Medical Systems, Inc. | 2014-06-13 |
| CORDIS SMART CONTROL NITINOL STENT SYSTEMS (P020036/S029) | Cordis US Corporation | 2014-06-13 |
| MIRACLIP CLIP DELIVERY SYSTEM (P100009/S001) | ABBOTT MEDICAL | 2014-06-13 |
| ATRICURE SYNERGY ABLATION SYSTEM (P100046/S004) | AtriCure, Inc. | 2014-06-13 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S043) | Medtronic | 2014-06-13 |
| RESTYLANE SILK SPHAL (P040024/S072) | Q-Med AB | 2014-06-13 |
| SMART CONTROL VASCULAR STENT SYSTEMS (P120002/S004) | Cordis US Corporation | 2014-06-13 |
| ELECSYS ANTI-HBC (P100031/S011) | Roche Diagnostics Corp. | 2014-06-12 |
| MEDTRONIC COREVALVE SYSTEM (P130021/S002) | Medtronic, Inc. | 2014-06-12 |
| ELECSYS ANTI-HBS (P010054/S023) | Roche Diagnostics Corp. | 2014-06-12 |
| ELECSYS FREE PSA (P000027/S019) | Roche Diagnostics Corp. | 2014-06-12 |
| ELECSYS TOTAL PSA (P990056/S021) | Roche Diagnostics Corp. | 2014-06-12 |
| AKREOS IOL (P060022/S019) | Bausch & Lomb, Inc. | 2014-06-12 |
| ORTHOVISC, HIGH MOLECULAR WEIGHT HYALURONAN (P030019/S019) | Anika Therapeutics, Inc. | 2014-06-12 |
| ELECSYS HBS AG (P990012/S021) | Roche Diagnostics Corp. | 2014-06-12 |
| ELESYS ANTI-HBC IGM (P110022/S012) | Roche Diagnostics Corp. | 2014-06-12 |
| ELECSYS ANTI-HCV (P090008/S013) | Roche Diagnostics Corp. | 2014-06-12 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S031) | Edwards Lifesciences, LLC | 2014-06-11 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S044) | Edwards Lifesciences, LLC | 2014-06-11 |
| TECNIS TORIC 1-PIECE INTRAOCULAR LENSES (IOL) (P980040/S043) | Johnson & Johnson Surgical Vision, Inc. | 2014-06-11 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S042) | Medtronic | 2014-06-11 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S009) | Torax Medical | 2014-06-11 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S005) | Bolton Medical, Inc. | 2014-06-11 |
| GENESYS HTA SYSTEM (P000040/S032) | Axora Medical, Inc. | 2014-06-10 |
| JUVEDERM VOLUMA XC (P110033/S008) | Allergan | 2014-06-10 |
| NEUROSTIMULATOR (ENS) (P970004/S173) | Medtronic Neuromodulation | 2014-06-10 |
| EXTERNAL NEUROSTIMULATOR (P080025/S069) | Medtronic Neuromodulation | 2014-06-10 |
| INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S001) | Inspire Medical Systems | 2014-06-09 |
| RX HERCULINK ELITE RENAL STENT SYSTEM (P110001/S011) | Abbott Vascular | 2014-06-06 |
| PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S199) | Boston Scientific Corp | 2014-06-06 |
| M-VU ALGORITHM ENGINE (P100005/S004) | Icad, Inc. | 2014-06-06 |
| ELECSYS HBEAG IMMUNOASSAY AND ELECSYS PRECICONTROL HBEAG (P130015/S001) | Roche Diagnostics Operations, Inc. | 2014-06-06 |
| PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S197) | Boston Scientific Corp | 2014-06-06 |
| SOFLENS 38 (POLYMACON) SOFT CONTACT LENSES (N16895/S095) | Bausch & Lomb, Inc. | 2014-06-06 |
| MONOVISC INJECTABLE INTRA-ARTICULAR DEVICE (P090031/S001) | Anika Therapeutics, Inc. | 2014-06-06 |
| LIFE VEST WEARABLE DEFIBRILLATOR (P010030/S050) | Zoll Manufacturing Corporation | 2014-06-06 |
| RX ACCULINK CAROTID STENT SYSTEM (P040012/S053) | Abbott Vascular | 2014-06-05 |
| VITAGEL RT3 DELIVERY SYSTEM (P050044/S028) | Stryker Corp. | 2014-06-05 |
| LCS TOTAL KNEE SYSTEM (P830055/S145) | Depuy, Inc. | 2014-06-05 |
| SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM STAR ANKLE (P050050/S006) | Djo Global | 2014-06-04 |
| GODRE TAG THORACIC ENDOPROSTHESIS (P040043/S060) | W. L. Gore & Associates, Inc. | 2014-06-04 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S086) | Boston Scientific Corp | 2014-06-04 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM, NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL SYSTEM WITH SURE (P010013/S056) | Hologic, Inc. | 2014-06-04 |
| SCS NEUROSTIMULATORS IMPLANTABLE ITREL, RESORE AND SYNERGY FAMILIES, (P840001/S260) | Medtronic Neuromodulation | 2014-06-04 |