| ADAPTA,VERSA,SENSIA IPG, ADVISA DR IPG,ADVISA DR MRI IPG,RELIA IPG (P980035/S368) | Medtronic, Inc. | 2014-04-04 |
| HEARTMATE II LVAS (P060040/S033) | ABBOTT MEDICAL | 2014-04-03 |
| ARCTIC FRONT CRYOABLATION CATHETER; ARCTIC FRONT ADVANCE CRYOABLATION CATHETER (P100010/S035) | Medtronic Cryocath, LP | 2014-04-03 |
| COMPLETE SE VASCULAR STENT SYSTEM-ILIAC (P090006/S014) | Medtronic Vascular | 2014-04-03 |
| COMPLETE SE VASCULAR STENT SYSTEM-SFA AND PPA (P110040/S005) | Medtronic Vascular | 2014-04-03 |
| ENLITE SENSOR (P120010/S014) | Medtronic, Inc. | 2014-04-03 |
| CORMET HIP RESURFACING SYSTEM (P050016/S010) | Corin USA | 2014-04-03 |
| MEDTRONIC COREVALUE TM SYSTEM, (P130021/S003) | Medtronic, Inc. | 2014-04-03 |
| TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM (P070027/S040) | Medtronic Vascular | 2014-04-03 |
| BIOCOR AND EPIC VALVE (P040021/S025) | ABBOTT MEDICAL | 2014-04-02 |
| SNS URINARY NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY (P080025/S064) | Medtronic Neuromodulation | 2014-04-02 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S017) | Boston Scientific Corporation | 2014-04-02 |
| SNS URINARY NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY (P970004/S168) | Medtronic Neuromodulation | 2014-04-02 |
| CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D AND PROTECTA XT CRT-D (P010031/S432) | Medtronic Cardiac Rhythm Disease Management | 2014-04-02 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S062) | W. L. Gore & Associates, Inc. | 2014-04-02 |
| ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT (P020018/S050) | Cook, Inc. | 2014-04-02 |
| MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD AND VIRTUOSO II DR VR ICD (P980016/S471) | Medtronic Cardiac Rhythm Disease Management | 2014-04-02 |
| ENLITE GLUCOSE SENSOR, ENLITE SERTER (P120010/S015) | Medtronic, Inc. | 2014-03-31 |
| INCEPTA,ENERGEN,PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATORS (P010012/S348) | Boston Scientific Corp | 2014-03-31 |
| INCEPTA,ENERGEN,PUNCTUA,TELIGEN IMPLANTABLE CARDIOVERTER HIGH ENERGY DEFIBRILLATORS (P960040/S311) | Boston Scientific | 2014-03-31 |
| REGENT/STANDARD/MASTERS MECHANICAL HEART VALVES (P810002/S089) | ABBOTT MEDICAL | 2014-03-31 |
| PROMOTE,QUADRA ASSURA,UNIFY,UNIFY ASSURA,UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S259) | ABBOTT MEDICAL | 2014-03-31 |
| IDENTITY,SUSTAINXL,VERITY,VICTORY,ZEPHYR,ACCENT FAMILIES OF PACEMAKER DEVICES (P880086/S238) | ABBOTT MEDICAL | 2014-03-31 |
| CURRENT,FORTIFY,FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S328) | ABBOTT MEDICAL | 2014-03-31 |
| ANTHEM FAMILY OF CRT-P DEVICES (P030035/S116) | ABBOTT MEDICAL | 2014-03-31 |
| VENTAK P AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM/ LEAD TUNNELER KIT (P830060/S078) | Boston Scientific | 2014-03-31 |
| ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S012) | LeMaitre Vascular, Inc. | 2014-03-28 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S030) | ABBOTT MEDICAL | 2014-03-28 |
| OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (P860047/S028) | Bausch & Lomb, Inc. | 2014-03-28 |
| FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM (P100028/S003) | Cook Medical Incorporated | 2014-03-28 |
| CYBERONICS VNS THERAPY SYSTEM (P970003/S168) | LivaNova USA, Inc. | 2014-03-28 |
| MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (MYNX PRODUCT FAMILY) (P040044/S049) | Cordis US Corporation | 2014-03-28 |
| VISTAKON SENOFILCON A BRAND CONTACT LENSES (P040045/S042) | Vistakon, Division of Johnson & Johnson Vision Car | 2014-03-28 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S028) | Edwards Lifesciences, LLC | 2014-03-28 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020) | Abbott Vascular (Idef Technologies Inc) | 2014-03-28 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S041) | Edwards Lifesciences, LLC | 2014-03-28 |
| CARPENTIER-EDEARDS DURAFLEX LOW PRESSURE PROCINE MITRAL BIOPROSTHESIS (P870077/S060) | Edwards Lifesciences, LLC | 2014-03-27 |
| CARPENTIER-EDWARDS PROCINE AORTIC BIOPROSTHESIS ,PROCINE MITRAL BIOPROSTHESIS (P870056/S066) | Edwards Lifesciences, LLC | 2014-03-27 |
| NATRELLE SALINE-FILLED BREAST IMPLANTS (P990074/S028) | Allergan | 2014-03-27 |
| LIFESTENT VASCULAR STENT SYSTEMS (P070014/S042) | Bard Peripheral Vascular, Inc. | 2014-03-27 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S049) | Edwards Lifesciences, LLC | 2014-03-27 |
| EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS (P000007/S045) | Edwards Lifesciences, LLC | 2014-03-27 |
| CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS (P010041/S049) | Edwards Lifesciences, LLC | 2014-03-27 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S036) | Edwards Lifesciences, LLC | 2014-03-27 |
| CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS WITH TERMAFIX TISSUE PROCESS, RSR PERICARDIAL AORTIC BIOP (P860057/S120) | Edwards Lifesciences, LLC | 2014-03-27 |
| EXPRESS 2 MONORAIL AND OVER-THE-WIRE (P020009/S118) | Boston Scientific Scimed, Inc. | 2014-03-26 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S124) | Boston Scientific Scimed, Inc. | 2014-03-26 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S032) | Medtronic | 2014-03-26 |
| CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S047) | Boston Scientific Corp | 2014-03-26 |
| BLAZER II XP CARDIAC ABLATION CATHETER AND CABLE (P020025/S054) | Boston Scientific | 2014-03-26 |
| OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEMS (P120006/S005) | Endologix, LLC | 2014-03-26 |
| NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION DEVICE (P010013/S053) | Hologic, Inc. | 2014-03-26 |
| ENLITE SENSOR (P120010/S013) | Medtronic, Inc. | 2014-03-26 |
| LEGOO (P110003/S004) | Genzyme Corp. | 2014-03-26 |
| EUFLEXXA (P010029/S019) | Ferring Pharmaceuticals, Inc. | 2014-03-26 |
| BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM AND BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR (P850022/S021) | Ahp Eos Buyer, Inc. | 2014-03-26 |
| ION PACLITAXEL -ELUTING CORONARY STENT SYSTEM (P100023/S089) | Boston Scientific Corp | 2014-03-26 |
| BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S066) | Boston Scientific Corp | 2014-03-26 |
| XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, OTW PLATFORM (P110019/S061) | Abbott Vascular | 2014-03-26 |
| ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE (P900056/S133) | Boston Scientific Corp | 2014-03-26 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S076) | Med-El Corp. | 2014-03-26 |
| EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S056) | Boston Scientific Corp | 2014-03-26 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S077) | Boston Scientific Corp | 2014-03-26 |
| PROXIMAL (D01) CONNECTOR (P820003/S127) | Medtronic Cardiac Rhythm Disease Management | 2014-03-26 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S057) | Boston Scientific Corp | 2014-03-25 |
| VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S125) | Boston Scientific Scimed, Inc. | 2014-03-25 |
| EXPRESS MONORAIL AND OTW CORONARY STENT SYSTEM (P020009/S119) | Boston Scientific Scimed, Inc. | 2014-03-25 |
| ION (TAXUS ELEMENT) CORONARY STENT SYSTEM (P100023/S090) | Boston Scientific Corp | 2014-03-25 |
| RESURE SEALANT (P130004/S004) | Ocular Therapeutix, Inc. | 2014-03-25 |
| CRYSTALENS ACCOMMODATING INTRAOCULAR LENS AND TRULIGN TORIC INTRAOCULAR LENS (P030002/S030) | Bausch & Lomb, Inc. | 2014-03-24 |
| THERAPY COOL PATH CATHETER (6 HOLE IRRIGATED) AND BI-DIRECTIONAL, SAFIRE BLU (6 HOLE IRRIGATED), SAFIRE BLU SP (P060019/S026) | Irvine Biomedical, Inc. | 2014-03-21 |
| THERAPY DUAL 8 CATHETER (NON-IRRIGATED), THERAPY 8MM THERMISTOR ABLATION CATHETER (NON-IRRIGATED), SAFIRE TX CATHETER (P040042/S026) | Irvine Biomedical,Inc.(Ibi) | 2014-03-21 |
| ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S072) | Terumo Medical Corporation | 2014-03-21 |
| LIVEWIRE TC ABLATION CATHETER (NON-IRRIGATED),SAFIRE ABLATION CATHETER (NON-IRRIGATED) (P960016/S044) | St Jude Medical | 2014-03-21 |
| ELECSYS HBSAG IMMUNOASSAY (P990012/S020) | Roche Diagnostics Corp. | 2014-03-21 |
| THERAPY CATHETER (NON-IRRIGATED) (P040014/S021) | Irvine Biomedical, Inc. | 2014-03-21 |
| ELECSYS ANTI-HBS IMMUNOASSAY (P010054/S022) | Roche Diagnostics Corp. | 2014-03-21 |
| ENLITE SENSOR (P120010/S012) | Medtronic, Inc. | 2014-03-21 |
| THERAPY COOL PATH DUO CATHETER(12 HOLE IRRIGATED),SAFIRE BLU DUO CATHETER(12 HOLE IRRIGATED),COOL PATH DUO ABLATION (P110016/S010) | ABBOTT MEDICAL | 2014-03-21 |
| ELECSYS FREE PSA IMMUNOASSAY (P000027/S018) | Roche Diagnostics Corp. | 2014-03-21 |
| ELECSYS ANTI-HBC IMMUNOASSAY (P100032/S009) | Roche Diagnostics Corp. | 2014-03-21 |
| PROTEGE SYSTEM (P010032/S074) | ABBOTT MEDICAL | 2014-03-21 |
| ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S020) | Roche Diagnostics Corp. | 2014-03-21 |
| OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES) (P940010/S011) | Pinnacle Biologics, Inc. | 2014-03-21 |
| NEUROPACE RNS SYSTEM (P100026/S013) | NeuroPace, Inc. | 2014-03-21 |
| NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEM (P130016) | Cochlear Americas | 2014-03-20 |
| CAPSUREFIX MRI LEAD (P090013/S134) | Medtronic, Inc. | 2014-03-20 |
| FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS (P030035/S108) | ABBOTT MEDICAL | 2014-03-20 |
| AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S230) | ABBOTT MEDICAL | 2014-03-20 |
| MICRONY FAMILY OF PACEMAKERS (P970013/S055) | ABBOTT MEDICAL | 2014-03-20 |
| LATTITUDE CONSULT SYSTEM (P910077/S138) | Boston Scientific | 2014-03-20 |
| ENLITE GLUCOSE SENSOR (P120010/S011) | Medtronic, Inc. | 2014-03-20 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S089) | MicroPort CRM USA, Inc. | 2014-03-20 |
| PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE DEVICE, PROCLOSE AT 6F SUTURE MEDIATED CLOSURE SYSTEM (P960043/S087) | Abbott Vascular, Inc. | 2014-03-20 |
| QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS (P030054/S241) | ABBOTT MEDICAL | 2014-03-20 |
| MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV) (P060038/S019) | Corcym Canada Corp | 2014-03-20 |
| ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS (P910023/S311) | ABBOTT MEDICAL | 2014-03-20 |
| TRIVASCULAR,INC OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM (P120006/S011) | Endologix, LLC | 2014-03-20 |
| CAPSUREFIX NOVUS LEAD (P930039/S106) | Medtronic, Inc. | 2014-03-20 |
| INVENIA ABUS (P110006/S003) | GE Healthcare | 2014-03-20 |