| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P130006/S010) | W. L. Gore & Associates, Inc. | 2014-07-31 |
| PREVELEAK SURGICAL SEALANT (P100030/S004) | Baxter Healthcare Corporation | 2014-07-31 |
| INTEGRITY CORONARY STENT SYSTEM (P030009/S079) | Medtronic, Ireland | 2014-07-31 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S070) | W. L. Gore & Associates, Inc. | 2014-07-31 |
| MEDSTREAM PROGRAMMABLE INFUSION PUMP (P890055/S056) | Intera Oncology | 2014-07-30 |
| VENTAK AV/PRIZM DR/VR, VITALITY, CONFIENT, TELIGEN, PUNCTUA, ENERGEN, & INCEPTA ICD'S (P960040/S323) | Boston Scientific | 2014-07-30 |
| JUVEDERM VOLUMA XC (P110033/S002) | Allergan | 2014-07-30 |
| SWEET TIP RX, SWEET PICOTIP RX, AND FLEXTEND LEADS (P960006/S043) | Boston Scientific | 2014-07-30 |
| EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S490) | Medtronic Cardiac Rhythm Disease Management | 2014-07-30 |
| AFX ENDOVASCULAR AAA SYSTEM (ACCESSORY STENT GRAFT DELIVERY SYSTEM (P040002/S049) | Endologix, LLC | 2014-07-30 |
| MEMORYGEL SILICONE GEL FILLED BREAST IMPLANTS (P030053/S018) | Mentor Corp. | 2014-07-30 |
| VERIFY EVALUATION SYSTEM FOR INTERSTIM THERAPY FOR BOWEL CONTROL (P080025/S075) | Medtronic Neuromodulation | 2014-07-30 |
| CONTAK RENEWAL TR, INVIVE AND INTUA CRT-P'S (P030005/S112) | Guidant Corp. | 2014-07-30 |
| THIN/LINE/FINELINE FAMILY OF ENDOCARDIAL PACING LEADS (P960004/S066) | Boston Scientific | 2014-07-30 |
| VERIFY EVALUATION SYSTEM FOR INTERSTIM THERPY FOR URINARY CONTROL (P970004/S179) | Medtronic Neuromodulation | 2014-07-30 |
| JUVEDERM VOLUMA XC (P110033/S010) | Allergan | 2014-07-30 |
| MYNXGRIP VASCULAR CLOSURE DEVICE (P040044/S056) | Cordis US Corporation | 2014-07-30 |
| INFORM HER2 DUAL ISH DNA PROBE COCKTAIL (P100027/S018) | Ventana Medical Systems, Inc. | 2014-07-30 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S027) | Smith & Nephew, Inc. | 2014-07-30 |
| VENTAK PRX AND VENTAK MINI (P910077/S145) | Boston Scientific | 2014-07-30 |
| ENDOTAK LEAD SYSTEM (P910073/S127) | Boston Scientific | 2014-07-30 |
| PROSTALUND CORETHERM SYSTEM AND PROSTALAND CORETHERM ACCESSORIES (P010055/S009) | Prostalund AB | 2014-07-30 |
| BRAVA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S452) | Medtronic Cardiac Rhythm Disease Management | 2014-07-30 |
| VENTAK (P830060/S080) | Boston Scientific | 2014-07-30 |
| CONTAK CD, EASYTRAK, LIVIAN, COGNIS, ACUITY SPIRAL, ENERGEN, PUNCTUA, & INCEPTA CRT-D'S (P010012/S363) | Boston Scientific Corp | 2014-07-30 |
| SELUTE LEAD SYSTEM (P950001/S027) | Boston Scientific | 2014-07-30 |
| JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S041) | Allergan | 2014-07-30 |
| VENTAK P2 PACEMAKER (P930035/S027) | Boston Scientific | 2014-07-30 |
| MEDTRONIC 3F AORTIC BIOPROSTHESIS MODEL 1000 (P060025/S013) | Medtronic, Inc. | 2014-07-30 |
| PULSAR, PULSAR MAX, INSIGNIA, ALTRUA, ADVANTIO & INGENIO PACEMAKERS (N970003/S166) | Boston Scientific Corp | 2014-07-30 |
| HIRESOLUTION BIONIC EAR SYSTEM (P960058/S108) | Advanced Bionics | 2014-07-29 |
| PARAGON CRT LENS (P050031/S001) | CooperVision, Inc. | 2014-07-28 |
| BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS (P010062/S008) | Bausch & Lomb | 2014-07-28 |
| SPRINT QUATTRO LEAD (P920015/S134) | Medtronic, Inc. | 2014-07-28 |
| DYNAGEN, INOGEN, ORIGEN EL ICD'S AND DYNAGEN, INOGEN, ORIGEN MINI ICD'S (P960040/S324) | Boston Scientific | 2014-07-28 |
| PARAGON CRT, PARAGON CRT 100, PARAGON RG-4 RIGID GAS PERMABLE CONTACT LENS (P870024/S049) | CooperVision, Inc. | 2014-07-28 |
| ADAPTA, VERSA, SENSIA IPG (P980035/S383) | Medtronic, Inc. | 2014-07-28 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S092) | MicroPort CRM USA, Inc. | 2014-07-28 |
| DYNAGEN CRT-D, X4 CRT-D, INOGEN CRT-D, X4CRT-D, OGIGEN CRT-D. X4 CRT-D (P010012/S364) | Boston Scientific Corp | 2014-07-28 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S036) | ABBOTT MEDICAL | 2014-07-27 |
| INTERSTIM THERAPY FOR BOWEL CONTROL (P080025/S074) | Medtronic Neuromodulation | 2014-07-25 |
| NOVOTTF-100A TREATMENT KIT (P100034/S009) | Novocure, GmbH | 2014-07-25 |
| ARTIC FRONT CYROABLATION CATHETER, ARTIC FRONT ADVANCE CRYOABLATION CATHETER (P100010/S040) | Medtronic Cryocath, LP | 2014-07-25 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER & XTRA SURGICAL CARDIAC CRYOABLATION DEVICE, 9F FREEZOR MAX SURGICAL CARDIAC (P020045/S058) | Medtronic Cryocath, LP | 2014-07-25 |
| ORTHOVISC (P030019/S021) | Anika Therapeutics, Inc. | 2014-07-25 |
| INTERSTIM THERAPY FOR UNINARY CONTROL (P970004/S178) | Medtronic Neuromodulation | 2014-07-25 |
| PRESTIGE LP CERVICAL DISC (P090029) | Medtronic Sofamor Danek USA, Inc. | 2014-07-24 |
| RAPID FFN CONTROL KIT (P920048/S008) | Hologic, Inc. | 2014-07-24 |
| BRAVA QUAD CRT-D, VIVA QUAD C CRT-D, VIVA QUAD S CRT-D, VIVA QUAD XT CRT-D (P010031/S453) | Medtronic Cardiac Rhythm Disease Management | 2014-07-24 |
| DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM (P120005/S025) | Dexcom, Inc. | 2014-07-24 |
| TECNIS OPTIBLUE 1-PIECE IOL (P980040/S048) | Johnson & Johnson Surgical Vision, Inc. | 2014-07-24 |
| ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S140) | Boston Scientific Corp | 2014-07-24 |
| SOF SENSOR (P980022/S158) | Medtronic Minimed | 2014-07-24 |
| INFUSE BONE GRAFT (P050053/S015) | Medtronic, Inc. | 2014-07-24 |
| INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S037) | Medtronic Sofamor Danek USA, Inc. | 2014-07-24 |
| NOVO TTF-100A SYSTEM (P100034/S008) | Novocure, GmbH | 2014-07-24 |
| ENLITE GLUCOSE SENSOR (P120010/S027) | Medtronic, Inc. | 2014-07-24 |
| FAMILY OF MERLIN@HOME TRANSMITTERS (P910023/S336) | ABBOTT MEDICAL | 2014-07-24 |
| DRUG DELIVERY CATHETERS (P860004/S209) | Medtronic, Inc. | 2014-07-24 |
| VIVA CRT-P (P010015/S243) | Medtronic, Inc. | 2014-07-24 |
| FAMILY OF MERLIN@HOME TRANSMITTERS (P030054/S268) | ABBOTT MEDICAL | 2014-07-24 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S045) | Vistakon, Division of Johnson & Johnson Vision Car | 2014-07-23 |
| HEART LASER CO2 TMR SYSTEM (P950015/S012) | Laser Engineering Heart, Inc. | 2014-07-23 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S047) | Medtronic, Inc. | 2014-07-23 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S046) | Medtronic, Inc. | 2014-07-23 |
| MOSIAC PORCINE BIOPROSTHESIS (P990064/S056) | Medtronic, Inc. | 2014-07-23 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT (P790007/S042) | Medtronic Heart Valves | 2014-07-23 |
| HANCOCK LOW POROSITY VALVED CONDUIT (P870078/S026) | Medtronic, Inc. | 2014-07-23 |
| LDR SPINE MOBI-C CERVICAL DISC PROTHESIS (ONE LEVEL INDICATION) (P110002/S007) | Highridge Medical, LLC | 2014-07-23 |
| LDR SPINE MOBI-C CERVICAL DISC PROSTHESIS (TWO LEVEL INDICATION) (P110009/S007) | Highridge Medical, LLC | 2014-07-23 |
| LOGICON CARIES DETECTOR (P980025/S002) | Carestream Dental, LLC | 2014-07-22 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S010) | Torax Medical | 2014-07-22 |
| EVERA S DR IC&, VR, XT DR, & XT VR ICD, MAXIMO II ICD, PROTECTA & XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S491) | Medtronic Cardiac Rhythm Disease Management | 2014-07-22 |
| BRAVA/ BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT ,VIVA QUAD S/XT/S CRT-D'S (P010031/S454) | Medtronic Cardiac Rhythm Disease Management | 2014-07-22 |
| SCS NEUROSTIMULATORS IMPLATABLE RESTORE FAMILY (P840001/S274) | Medtronic Neuromodulation | 2014-07-22 |
| ENLITE SENSOR (P120010/S028) | Medtronic, Inc. | 2014-07-22 |
| GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S102) | W. L. Gore & Associates, Inc. | 2014-07-21 |
| PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMS (P110010/S083) | Boston Scientific Corp | 2014-07-18 |
| INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER (P020025/S063) | Boston Scientific | 2014-07-18 |
| LIFE STENT VASCULAR STENT SYSTEMS (P070014/S044) | Bard Peripheral Vascular, Inc. | 2014-07-18 |
| ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS MOBILE BEARING KNEE (P060037/S026) | Zimmer, Inc. | 2014-07-18 |
| QUADRA ASSURA, UNIFY, UNIFY ASSURA AND UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S272) | ABBOTT MEDICAL | 2014-07-18 |
| MYSENTRY SYSTEM, MYSENTRY MONITOR, MYSENTRY OUTPOST (P980022/S157) | Medtronic Minimed | 2014-07-18 |
| FORTIFY AND FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S341) | ABBOTT MEDICAL | 2014-07-18 |
| EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S063) | Boston Scientific Corp | 2014-07-18 |
| FREEZOR CARDIAC CRYOABLATION CATHETER; FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE (P020045/S054) | Medtronic Cryocath, LP | 2014-07-17 |
| VNS THERAPY LEAD, MODEL 302,VNS THERAPY PERENNIADURA LEAD,MODEL 303,VNS THERAPY PERENNIAFLEX LEAD MODEL 304 (P970003/S172) | LivaNova USA, Inc. | 2014-07-17 |
| CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, & PROTECTA XT CRT-D'S (P010031/S449) | Medtronic Cardiac Rhythm Disease Management | 2014-07-17 |
| HYDRELLE (P050033/S016) | Anika Therapeutics, Inc. | 2014-07-17 |
| VECTRIS SURESCAN MRI LEADS 1X8 SUBCOMPACT & COMBACT, VECTRIS TRIAL SCREENING LEAD 1X8 SUBCOMPACT & COMPACT (P840001/S272) | Medtronic Neuromodulation | 2014-07-17 |
| MAXIMO II, PROTECTA, PROTECTA XT, SECURA, & VIRTUOSO II DR/VR ICD'S (P980016/S487) | Medtronic Cardiac Rhythm Disease Management | 2014-07-17 |
| EON, EON MINI AND PROTEGE IPG'S (P010032/S082) | ABBOTT MEDICAL | 2014-07-17 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LVAS (P060040/S037) | ABBOTT MEDICAL | 2014-07-17 |
| REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR (P950029/S091) | MicroPort CRM USA, Inc. | 2014-07-16 |
| REOCOR S/D EXTERNAL PACEMAKER (P950037/S135) | Biotronik, Inc. | 2014-07-16 |
| TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S039) | Medtronic Vascular | 2014-07-16 |
| LATITUDE NXT PATIENT MANAGEMENT SYSTEM, LATITUDE NXT RELEASE 3.0 (P910077/S143) | Boston Scientific | 2014-07-16 |
| COGNIS, PROGENY CRT-D AND NG CRT-D MODELS (P010012/S355) | Boston Scientific Corp | 2014-07-16 |
| TELIGEN, PROGENY ICD AND NG ICD MODELS (P960040/S316) | Boston Scientific | 2014-07-16 |
| PATH VYSION HER-2 DNA PROBE KIT (P980024/S013) | Abbott Molecular, Inc. | 2014-07-16 |